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Urgent field safety notice to syngo RT Therapist / syngo RT Oncologist, Siemens AG PDF, 24KB, File does not meet accessibility standards Date: 29. January 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 07846/15

Safety advisory notice for quench line of superconducting magnets, Siemens Healthcare GmbH PDF, 1MB, File does not meet accessibility standards Date: 29. January 2016 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 09166/15

Urgent field safety notice for Bond Polymer Refine Red Detection, Leica Biosystems Newcastle Ltd. PDF, 1MB, File does not meet accessibility standards Date: 29. January 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 09157/15

Corrective action for CONTOUR NEXT control solutions, Bayer HealthCare / Diabetes Care PDF, 184KB, File does not meet accessibility standards Date: 29. January 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 08774/15

Recall of MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE® 30 Blue Curved Tip Cartridge, CARDICA GmbH PDF, 146KB, File does not meet accessibility standards Date: 28. January 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 08824/15

Urgent field safety notice for Etest PIP/TAZO/CON‐4 PTC 256, bioMérieux SA PDF, 534KB, File does not meet accessibility standards Date: 28. January 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 08929/15

Urgent field safety notice for Optima CL323i and Optima IGS 320 systems, GE Healthcare PDF, 75KB, File does not meet accessibility standards Date: 28. January 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 08906/15

Urgent field safety notice for Y Connector 8-10mm, Vygon (UK) Ltd. PDF, 227KB, File does not meet accessibility standards Date: 28. January 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 07019/15

Urgent field safety notice for A. V. Fistula sets for Hemodialysis, Asahi Kasei Medical Europe GmbH / Kawasumi Laboratories Inc. PDF, 869KB, File does not meet accessibility standards Date: 28. January 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - injection kits
Reference 08694/15

Urgent field corrective action for ADVIA Centaur / ADVIA Centaur XP, Siemens Healthcare Diagnostics Inc. PDF, 40KB, File does not meet accessibility standards Date: 28. January 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 08847/15

Urgent field safety notice for Cellistypt, Cellistypt D-K and Cellistypt F, Synthesia a. s. / BBraun Surgical, S. A. PDF, 266KB, File does not meet accessibility standards Date: 28. January 2016 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - ointments and gels
Reference 08846/15

Field safety notice for Natrelle 133 Plus Tissue Expanders, Allergan PDF, 29KB, File does not meet accessibility standards Date: 28. January 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 08091/15

Urgent field safety notice for QUADROX-iD Adult/Small Adult, HLS Set Advanced / HIT Set Advanced, PLS Set / HIT Set PLS / HIT Set PLS Plus, Maquet Cardiopulmonary GmbH PDF, 2MB, File does not meet accessibility standards Date: 28. January 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 08724/15

Urgent field safety notice for Spiral Line ProSet, B. Braun Melsungen AG PDF, 44KB, File does not meet accessibility standards Date: 28. January 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 07549/15

Field safety notice for Dialog+ SW 9.xx Dialysis Machines, B. Braun Avitum AG PDF, 112KB, File does not meet accessibility standards Date: 28. January 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 08707/15

Field Safety Notice for Chariot Guiding Sheath, Boston Scientific International S. A. PDF, 587KB, File does not meet accessibility standards Date: 28. January 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 08808/15

Corrective action for DGDE DirectGuide Drill Extender, Implant Direct Sybron Manufacturing LLC PDF, 130KB, File does not meet accessibility standards Date: 28. January 2016 Topics: Medical devices Type: Customer information

Product group Dental products - dental implants
Reference 08439/15

Corrective action for AlignRT/GateRT, VisionRT Ltd. PDF, 388KB, File does not meet accessibility standards Date: 27. January 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 08511/15

Urgent Field Safety Notice for Destination Renal Guiding Sheath, Terumo Europe N. V. PDF, 104KB, File does not meet accessibility standards Date: 27. January 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 08784/15

Urgend Field Safety Notice for Sysmex CA-/CS-Systems with Factor VIII Chromogenic Assay lot, Siemens Healthcare Diagnostics Products GmbH PDF, 695KB, File does not meet accessibility standards Date: 27. January 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 08241/15

Brain Metastases Version 1.0.0 and Adaptive Hybrid Surgery Analysis Version 1.0.0, Brainlab AG PDF, 597KB, File does not meet accessibility standards Date: 27. January 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 08759/15

Recall of attachment for acetabular and medullary reaming, DePuy Synthes PDF, 62KB, File does not meet accessibility standards Date: 27. January 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 07937/15

Urgent safety notice Allura Xper FD R8.2.0, Philips Healthcare PDF, 107KB, File does not meet accessibility standards Date: 27. January 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 08733/15

Corrective action for proGAV / proGAV 2.0, Christoph Miethke GmbH & Co. KG PDF, 2MB, File does not meet accessibility standards Date: 27. January 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 08663/15

Corrective action for Medfusion Stopcocks, Smiths Medical PDF, 186KB, File does not meet accessibility standards Date: 27. January 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion kits
Reference 05272/15

Safety Notice for the ECG electrode, Leonhard Lang GmbH PDF, 222KB, File does not meet accessibility standards Date: 16. December 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 08371/15

Corrective action for the CardioCall ECG Event Recorder, Spacelabs Healthcare PDF, 74KB, File does not meet accessibility standards Date: 15. December 2015 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 07542/15

Urgent Safety Notice Stratus® CS Acute Care™ Diagnostics System, Siemens Healthcare Diagnostics Inc. PDF, 58KB, File does not meet accessibility standards Date: 15. December 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 08681/15

Corrective action for the ARCTIC SUN® 5000 Temperature Management System, Bard Medical Division PDF, 172KB, File does not meet accessibility standards Date: 15. December 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 08682/15

Recall for TRACOE larynx stoma button and TRACOE larynx grid button, Tracoe medical GmbH PDF, 306KB, File does not meet accessibility standards Date: 15. December 2015 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - care of natural and artificial body orifices
Reference 08700/15