BfArM - Federal Institute for Drugs and Medical Devices

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Information concerning the Hemodialysis System 1000 from Baxter PDF, 85KB, File does not meet accessibility standards Date: 26. July 2007 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 02357/07

Corrective action of the Elecsys PTH Reagent from Roche PDF, 48KB, File does not meet accessibility standards Date: 26. July 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 01867/07

Information concerning theStockert EP-Shuttle Generator from Biosense Webster PDF, 23KB, File does not meet accessibility standards Date: 26. July 2007 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices
Reference 02307/07

Corrective action of the Elekta Synergy linear accelerator from Elekta Oncology Systems PDF, 116KB, File does not meet accessibility standards Date: 26. July 2007 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection
Reference 00340/07

Information about peripheral monitors from Edwards Lifesciences PDF, 56KB, File does not meet accessibility standards Date: 25. July 2007 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices
Reference 02438/07

Recall of circular stapler and hemorrhoidal stapler by Stapleline Medizintechnik PDF, 76KB, File does not meet accessibility standards Date: 25. July 2007 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans
Reference 02275/07

Corrective action of ADVIA Centaur, Centaur XP and Centaur CP in combination with the TnI-Ultra Assay from Siemens PDF, 103KB, File does not meet accessibility standards Date: 25. July 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02084/07

Recall for FC 500 with CXP 2.2 Acquisition Software and FC500 MPL with MXP 2.1 Acquisition Software of Beckman Coulter PDF, 44KB, File does not meet accessibility standards Date: 19. July 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02418/07

Information about Ortho Clinical Diagnostics Mitis2 System from Ortho PDF, 100KB, File does not meet accessibility standards Date: 19. July 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02347/07

Information about HeartStart XL M4735 from Philips Medizinsysteme Böblingen PDF, 160KB, File does not meet accessibility standards Date: 19. July 2007 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices
Reference 02402/07

Recall of the N’Vision Application Cards Model 8870 NNB_01 (InterStim-B software) from Medtronic PDF, 262KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices
Reference 02390/07

Corrective action on the MKONA Kit (lot number 01BG) of the Privates Institut für Immunologie und Molekulargenetik PDF, 33KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02300/07

Recall of the NEWAY DR pacemakers from Sorin PDF, 151KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices
Reference 02181/07

Recall of the urinary collecting bags Norta Urobag S from BSN Medical PDF, 88KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology
Reference 01715/07

Information concerning the iris fixated phakic intraocular lenses Verisyse and VeriFlex from AMO (Advanced Medical Optics) PDF, 77KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 01190/07

Information concerning possible under delivery of enteral products from Abbott PDF, 57KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 02184/07

Safety related change of the user manual of the Legendair ventilator from Tyco Healthcare PDF, 183KB, File does not meet accessibility standards Date: 17. July 2007 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia
Reference 02195/06

Recall of the Ranger Standard Flow Disposable Blood/Fluid Warming sets from Arizant Healthcare PDF, 142KB, File does not meet accessibility standards Date: 13. July 2007 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 02389/07

Software upgrade of the LOGIQ 3 Expert ultrasound scanner from GE Healthcare PDF, 56KB, File does not meet accessibility standards Date: 13. July 2007 Topics: Medical devices Type: Customer information

Product group Ultrasonics
Reference 01826/07

Recall of the Morcellator Cutters 12 mm for Use with RotoCut G1 System from Karl Storz GmbH & Co. KG PDF, 42KB, File does not meet accessibility standards Date: 13. July 2007 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering
Reference 01632/07