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Corrective action for UniCel DxH 800 and 600 Coulter Cellular Analysis Systems, Beckman Coulter PDF, 314KB, File does not meet accessibility standards Date: 04. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 05935/13

Corrective action for Dimension Clinical Chemistry Systems LOCI Cardiac Troponin I Calibrator, Siemens PDF, 70KB, File does not meet accessibility standards Date: 04. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05654/13

ossibility of leaking packages of several products of the Tissue Guard product family, Synovis Surgical Innovations PDF, 50KB, File does not meet accessibility standards Date: 04. December 2013 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 04131/13

Asid Bonz GmbH: Safety Notice for the product Aerosol nebulizer with mask, adult PDF, 307KB, File does not meet accessibility standards Date: 04. December 2013 Topics: Medical devices Type: Customer information

Product group Physical therapy - inhalation therapy
Reference 02952/13

Safety Notice for the Instrument Star Unit ML, Brainlab PDF, 339KB, File does not meet accessibility standards Date: 04. December 2013 Topics: Medical devices Type: Customer information

Product group Radiological technology - navigation systems
Reference 07106/13

Safety Notice for the Bright View XCT Imaging System, Philips Healthcare PDF, 291KB, File does not meet accessibility standards Date: 04. December 2013 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 05832/13

Corrective action for the Cedia Tobramycin II Assay, Microgenics PDF, 2MB, File does not meet accessibility standards Date: 04. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06462/13

Safety Notice for the (AMO) STAR Excimer Laser System, Abbott Medical Optics, Inc. PDF, 213KB, File does not meet accessibility standards Date: 03. December 2013 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 05704/13

Field Safety Notice Odalys sterile rods PDF, 2MB, File does not meet accessibility standards Date: 03. December 2013 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 06118/13

Lot Recall of the Versys® Hip System Cemented Revision/Calcar Femoral Stem, Versys Heritage® Hip Prosthesis Femoral Revision Stem, Zimmer Inc. PDF, 127KB, File does not meet accessibility standards Date: 03. December 2013 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05950/13

Safety Notice for CentraLink™ Data Management System, Siemens Healthcare Diagnostics PDF, 27KB, File does not meet accessibility standards Date: 03. December 2013 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 06609/13

Recall for the Tibial Resection Guide, Biomet PDF, 4MB, File does not meet accessibility standards Date: 03. December 2013 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06770/13

Safety Notice for the Artist System, Siemens Healthcare PDF, 19KB, File does not meet accessibility standards Date: 03. December 2013 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 07089/13

Safety Notice / Correction for the Patient Side Manipulators on the da Vinci S, Si and Si-e Patient Side Cart, Intuitive Surgical, Inc. PDF, 584KB, File does not meet accessibility standards Date: 02. December 2013 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 06862/13

Recall for Oxoid Yersinia – Selective Supplement, Oxoid PDF, 25KB, File does not meet accessibility standards Date: 02. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 06531/13

Safety Notice for the AGC Tibial and AGC Femoral Impactor, Biomet UK Ltd. PDF, 2MB, File does not meet accessibility standards Date: 02. December 2013 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06884/13

Recall of the 13F/15F Navigator™ HD Ureteral Access Sheath Set, Boston Scientific PDF, 92KB, File does not meet accessibility standards Date: 02. December 2013 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 06798/13

Recall (Phase 2) of the Trabecular Metal™ Reverse Glenosphere Distractor, Zimmer Inc. PDF, 2MB, File does not meet accessibility standards Date: 02. December 2013 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 05052/13

Lot Recall of the Carotis Sets, Mölnlycke Health Care PDF, 100KB, File does not meet accessibility standards Date: 02. December 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Reference 06073/13

Recall for the FiberOptix IAB Catheter, Arrow International Inc. PDF, 218KB, File does not meet accessibility standards Date: 02. December 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06672/13

Urgent Safety Notice for the Stryker Dekompressor® Percutaneous Discectomy Probes, Stryker PDF, 109KB, File does not meet accessibility standards Date: 28. November 2013 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06979/13

Recall of Breeze C Scooters, Afikim Electric Vehicles PDF, 46KB, File does not meet accessibility standards Date: 28. November 2013 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 05856/13

Recall (phase 2) of the Trabecular Metal Reverse Glenosphere Helmets, Zimmer PDF, 2MB, File does not meet accessibility standards Date: 28. November 2013 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04557/13

Recall of the IN.PACT® Amphirion Drug-Eluting Balloon (DEB), Medtronic PDF, 69KB, File does not meet accessibility standards Date: 28. November 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06771/13

Recall of the Universal Set with MSC products, Mölnlycke Health Care AB PDF, 24KB, File does not meet accessibility standards Date: 28. November 2013 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 05779/13

Corrective action for ACL AcuStar System Software, Instrumentation Laboratory PDF, 21KB, File does not meet accessibility standards Date: 28. November 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 05452/13

Recall for TRANSRADIAL ARTERY ACCESS KITS, Arrow International Inc. PDF, 136KB, File does not meet accessibility standards Date: 28. November 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06094/13

Recall of ADROIT™ 6F Guiding Catheters, Cordis PDF, 69KB, File does not meet accessibility standards Date: 28. November 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 04811/13

Urgent Safety Notice for the Philips Expression Information Portal (IP5), Philips PDF, 125KB, File does not meet accessibility standards Date: 27. November 2013 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 06994/13

Voluntary Recall of Anaconda™-ONE-LOK Bifurcate Body and Anaconda™ Bifurcate Body, VASCUTEK Ltd. PDF, 2MB, File does not meet accessibility standards Date: 27. November 2013 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 06372/13