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Safety Notice for the Brilliance iCT system, Philips Healthcare PDF, 285KB, File does not meet accessibility standards Date: 10. December 2013 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 06479/13

Recall of several Zenith Ankle Tibial Inserts, Corin PDF, 3MB, File does not meet accessibility standards Date: 10. December 2013 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05946/13

Urgent Safety Notice for the Obalon Inflation System, Obalon Therapeutics, Inc. PDF, 78KB, File does not meet accessibility standards Date: 10. December 2013 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 05585/13

Corrective action for r ex-tem Reagent, TEM Innovations GmbH PDF, 73KB, File does not meet accessibility standards Date: 10. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 06942/13

Recall of Sleep Safe Sets, Fresenius Medical Care GmbH PDF, 2MB, File does not meet accessibility standards Date: 10. December 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 07054/13

Corrective action for ADVIA Chemistry Systems rer, Siemens PDF, 131KB, File does not meet accessibility standards Date: 10. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06950/13

Corrective action for Indiko, Indiko Plus, Gallery, Gallery Plus und Gallery Plus Beer Master Analyzers, Thermo Fisher PDF, 2MB, File does not meet accessibility standards Date: 10. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05218/13

Corrective action for MagNA Pure 96 Instrument, Roche PDF, 131KB, File does not meet accessibility standards Date: 10. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06701/13

Safety Notice for ADAC ARGUS and CIRRUS Gama Camera Systems, Philips Healtcare PDF, 208KB, File does not meet accessibility standards Date: 10. December 2013 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 06973/13

Field Safety Notice concerning updated instructions for use and labelling of beds Contura 1000 and 1080, ArjoHuntleigh PDF, 223KB, File does not meet accessibility standards Date: 10. December 2013 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 05949/13

Field Corrective Action to patient chairs TENEO, Sirona Dental Systems GmbH PDF, 394KB, File does not meet accessibility standards Date: 09. December 2013 Topics: Medical devices Type: Customer information

Product group Dental products - dental treatment units
Reference 06497/13

Recall for the software application card used in the 8840 N’Vision clinician programmer, Medtronic PDF, 79KB, File does not meet accessibility standards Date: 09. December 2013 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - drug pumps
Reference 05818/13

Recall for Medex Angiographic-Puncture Needles, Smiths Medical PDF, 7MB, File does not meet accessibility standards Date: 09. December 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06652/13

Expanded Recall for the Occlusion Catheters, Teleflex Medical GmbH PDF, 332KB, File does not meet accessibility standards Date: 09. December 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 02609/13

Important Product Information for HomeChoice and HomeChoice Pro Devices, Baxter PDF, 64KB, File does not meet accessibility standards Date: 09. December 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 06718/13

Recall of one batch of the Reflection Polyethylene Acetabular Liners, Smith & Nephew PDF, 1MB, File does not meet accessibility standards Date: 09. December 2013 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 07107/13

Recall of specific lots of the Large Needle Driver and Mega Needle Driver EndoWrist® Instruments for da Vinci® Surgical Systems, Intuitive Surgical PDF, 435KB, File does not meet accessibility standards Date: 09. December 2013 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 07169/13

Field Safety Notice with Navigation Software Spine & Trauma 3D 2.0, Brainlab Field Safety Notice with Navigation Software Spine & Trauma 3D 2.0, Brainlab PDF, 553KB, File does not meet accessibility standards Date: 09. December 2013 Topics: Medical devices Type: Customer information

Product group Radiological technology - navigation systems
Reference 06940/13

Safety Information concerning the HP M.B.T. Keel Punch Knee Instruments, DePuy Synthes PDF, 174KB, File does not meet accessibility standards Date: 06. December 2013 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 07116/13

Recall Offset Adapter A-642100, Össur PDF, 39KB, File does not meet accessibility standards Date: 06. December 2013 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - prostheses (exoprostheses)
Reference 06546/13

Recall for the Cup Insertion Instrument W/Thread M8X1 CVD, Aesculap AG PDF, 2MB, File does not meet accessibility standards Date: 06. December 2013 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06757/13

Recall oXiris set for acute dialysis therapy, Gambro PDF, 566KB, File does not meet accessibility standards Date: 06. December 2013 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 05911/13

Corrective action for Advia Chemistry Calibrator, Siemens PDF, 27KB, File does not meet accessibility standards Date: 06. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05936/13

Field Safety Notice for GSI Viewer on Advantage Worksation products, GE Healthcare PDF, 277KB, File does not meet accessibility standards Date: 06. December 2013 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 05866/13

Medical Device Labelling Correction to TomoFix Medial High Tibia Plate, DePuy Synthes/ Swiss Date: 06. December 2013 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05837/13

Corrective action for RapiD 20 E, Biomerieux PDF, 87KB, File does not meet accessibility standards Date: 06. December 2013 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05852/13

Recall of the E-vita THORACIC 3G Stent Graft System, Jotec GmbH PDF, 988KB, File does not meet accessibility standards Date: 05. December 2013 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 06905/13

Safety Notice for ultrasound systems APLIO XG and MX, XARIO and XARIO XG, Toshiba PDF, 1MB, File does not meet accessibility standards Date: 05. December 2013 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 06566/13

Recall of and Important Field Safety Notice on Synergy Micro-pump system implantable left-ventricular assist devices, CircuLite PDF, 238KB, File does not meet accessibility standards Date: 05. December 2013 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 04341/13

Batch Recall of the Toptex lite Laparotomy swabs, Lohmann & Rauscher PDF, 30KB, File does not meet accessibility standards Date: 05. December 2013 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - swabs, sponges, wipes, swabsticks
Reference 07082/13