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Corrective action for the Pak12, Immucor GTI Diagnostics PDF, 105KB, File does not meet accessibility standards Date: 19. October 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 06527/15

Corrective action for the seleXys TH+ and seleXys TPS shells, Mathys Ltd. Bettlach PDF, 61KB, File does not meet accessibility standards Date: 19. October 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 06646/15

Urgent Safety Notice for the Multigent Ammonia Ultra Reagent, Sentinel CH. Spa PDF, 2MB, File does not meet accessibility standards Date: 19. October 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 06833/15

Corrective action for the Heater Cooler Unit HCU 30, Maquet Cardiopulmonary GmbH PDF, 92KB, File does not meet accessibility standards Date: 19. October 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 07482/15

Safety Corrective action for the femoral neck component, MicroPort Orthopedics PDF, 383KB, File does not meet accessibility standards Date: 19. October 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05610/15

Recall for the RotaWire Elite™ Guidewire and wireClip™ Torquer Guidewire Manipulation Device, Boston Scientific International S.A. PDF, 317KB, File does not meet accessibility standards Date: 19. October 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 07499/15

Urgent Safety Notice for TheraSphere®-Y-90 Glass Microspheres, Biocompatibles UK Ltd. (BTG), PDF, 1MB, File does not meet accessibility standards Date: 19. October 2015 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - implantats emitting radioactive radiation
Reference 06761/15

Urgent Safety Notice RAPIDPoint® 500 System, Siemens Healthcare Diagnostics Inc. PDF, 73KB, File does not meet accessibility standards Date: 19. October 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06975/15

Corrective action for the MetaVision® Suite, Clinical Information System - version 5.47, iMDsoft PDF, 408KB, File does not meet accessibility standards Date: 15. October 2015 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - others
Reference 05602/15

Recall for Endotracheal tubes, Vygon PDF, 151KB, File does not meet accessibility standards Date: 15. October 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 06389/15

Corrective action for Tests based on trinder reactions, Thermo Fisher Scientific Oy PDF, 3MB, File does not meet accessibility standards Date: 15. October 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06765/15

Corrective action involving the P3 Medical Vented Tracheal Tube Guides (Bougies), P3 Medical Limited PDF, 85KB, File does not meet accessibility standards Date: 15. October 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 06680/15

Corrective action for the ARCHITECT i2000SR System, Abbott PDF, 2MB, File does not meet accessibility standards Date: 15. October 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 06486/15

Urgent Safety Notice for the Neuro Omega system, Alpha Omega Engineering Ltd. PDF, 290KB, File does not meet accessibility standards Date: 15. October 2015 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 06016/15

Safety Notice for the Arrow® Pressure Injectable Peripherally Inserted Central Catheter (PICC) – 4FR, Arrow International, Inc. PDF, 137KB, File does not meet accessibility standards Date: 15. October 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06983/15

Recall for specific lots of LFIT V40 Tapers, V40 Tapers and PCA Tapers Vitallium Femoral Heads, STRYKER® ORTHOPAEDICS PDF, 69KB, File does not meet accessibility standards Date: 15. October 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 06414/15

Safety Notice for the Allura Xper FD Systems, Philips Healthcare PDF, 373KB, File does not meet accessibility standards Date: 15. October 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 06863/15

Safety Notice for the RSP Monoblock Fixture, Encore Medical dba DJO Surgical LLC PDF, 688KB, File does not meet accessibility standards Date: 15. October 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06880/15

Corrective action for the Enteral Syringe Pumps P500, P700 and P900, Medicina Ltd. PDF, 303KB, File does not meet accessibility standards Date: 14. October 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 05841/15

Safety Notice for the BD Plastipak Syringes / BD Oral Syringes, Becton Dickinson GmbH PDF, 305KB, File does not meet accessibility standards Date: 14. October 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 06769/15

Recall for MOSAICPLASTY™ Kits (MOSAICPLASTY DP – Disposable Harvesting System), Smith & Nephew, Inc. PDF, 103KB, File does not meet accessibility standards Date: 14. October 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06478/15

Corrective action for the Brainlab iMRI Registration Matrix for GE, Brainlab AG PDF, 693KB, File does not meet accessibility standards Date: 14. October 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - navigation systems
Reference 06865/15

Recall for Brainlab Disposable Reflective Marker Spheres (DRMS), Brainlab AG PDF, 445KB, File does not meet accessibility standards Date: 14. October 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - special surgical instruments
Reference 05666/15

Recall for the Laryngeal Suction Tube with Soft Tip, Pennine Healthcare PDF, 1MB, File does not meet accessibility standards Date: 14. October 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 06789/15

Safety Notice for Völker nursing beds, Völker GmbH PDF, 201KB, File does not meet accessibility standards Date: 14. October 2015 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 02248/15

Safety Notice for the Philips Allura Xper FD, Philips Healthcare PDF, 107KB, File does not meet accessibility standards Date: 14. October 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 06638/15

Urgent Field Safety Notice for ADVIA®Chemistry Systems, Alkaline Phosphatase, Siemens Healthcare Diagnostics PDF, 41KB, File does not meet accessibility standards Date: 13. October 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 07119/15

Urgent Field Safetv Notice for LIAISON® Cortisol, DiaSorin PDF, 2MB, File does not meet accessibility standards Date: 13. October 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 07008/15

Field Safety Notice for users of the MODULARIS Variastar, Siemens Healthcare GmbH PDF, 1MB, File does not meet accessibility standards Date: 13. October 2015 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic therapeutic equipment
Reference 07013/15

Updated Instructions for Use for the Navigated Solera Screwdrivers, Medtronic PDF, 254KB, File does not meet accessibility standards Date: 13. October 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 06752/15