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Corrective action for the Integra® Licox® Test Sets (BC10R) of the manufacturer GMS, Integra LifeSciences Corporation PDF, 158KB, File does not meet accessibility standards Date: 11. August 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 02299/14

Urgent Safety Notice for the Standard Uniflow Co-Axial Breathing System, 2 m, Intersurgical UAB PDF, 111KB, File does not meet accessibility standards Date: 11. August 2014 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 04206/14

Corrective action for the Washer‐Disinfector of GETINGE Getinge 46‐Series (CM302) with PACS 300/350 control, Getinge Disinfection AB PDF, 169KB, File does not meet accessibility standards Date: 11. August 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 03741/14

Follow-up Information for Access Immunoassay Systems and UniCel DxI Immunoassay Systems, Beckman Coulter PDF, 29KB, File does not meet accessibility standards Date: 07. August 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 02259/11

Updated Safety Information for the Synthes Trauma External Fixation System (Small, Medium, Distraction Osteogenesis (DO) Ring and Large, Synthes GmbH PDF, 1MB, File does not meet accessibility standards Date: 07. August 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 02343/14

Urgent Safety Information for the PEGASUS 3-D-System, BfMC Biofeedback Motor Control GmbH PDF, 145KB, File does not meet accessibility standards Date: 07. August 2014 Topics: Medical devices Type: Customer information

Product group Physical therapy - massage / mobility devices
Reference 04299/14

Corrective action for the product COSEAL Surgical Sealant 2ml and 4ml, Baxter Healthcare Corporation PDF, 94KB, File does not meet accessibility standards Date: 07. August 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 04623/14

Important Safety Notice for the Symbia T Series and Symbia Intevo camera system, Siemens Medical Solutions USA, Inc. PDF, 829KB, File does not meet accessibility standards Date: 07. August 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 04594/14

Corrective action for the Allura XPER Systems, Philips Healthcare PDF, 199KB, File does not meet accessibility standards Date: 07. August 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 04399/14

Corrective action concerning the use of endoscopic accessories with Pentax Video Gastroscopes (Gas/Water Feeding Valves), HOYA CORPORATION PENTAX Life care Division PDF, 386KB, File does not meet accessibility standards Date: 06. August 2014 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 02641/13

Recall for the HKS Sets - Customized Catheter Kits, Maquet Cardiopulmonary AG PDF, 532KB, File does not meet accessibility standards Date: 06. August 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 04544/14

Recall for Tissue Morcellation System, Ethicon PDF, 124KB, File does not meet accessibility standards Date: 05. August 2014 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 04570/14

Urgent Safety Notice concerning the use of the Ultrafilter U9000, Gambro Dialysatoren GmbH PDF, 699KB, File does not meet accessibility standards Date: 04. August 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 04515/14

Corrective action for the MobileDiagnost wDR X-ray systems, Philips Medizin Systeme PDF, 151KB, File does not meet accessibility standards Date: 04. August 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 04423/14

Corrective action for the FlowCoupler Device, Synovis Micro Companies Alliance, Inc. PDF, 140KB, File does not meet accessibility standards Date: 01. August 2014 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 04124/14

Urgent Safety Notice: Corrective action for the Affinity™ Four Birthing Bed - Lift-Off Foot Section, Hill-Rom PDF, 1,001KB, File does not meet accessibility standards Date: 01. August 2014 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 04474/14

Follow-up Information: Recall for the DePuy S‐ROM Noiles Rotating Hinge Femur with Pin PDF, 854KB, File does not meet accessibility standards Date: 01. August 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 01392/14

Recall for the CloverSnare 4-Loop Vascular Retrieval Snare, Cook Incorporated PDF, 22KB, File does not meet accessibility standards Date: 01. August 2014 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - vascular surgery
Reference 04035/14

Corrective action for the Philips Expression MR200 MRI Patient Monitoring System, Philips Healthcare PDF, 185KB, File does not meet accessibility standards Date: 01. August 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 04469/14

Corrective action for the Expression IP5 Information Portal, Philips Healthcare PDF, 165KB, File does not meet accessibility standards Date: 01. August 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 04493/14

Urgent Safety Notice for the E.cam and Symbia E collimator carts, Siemens Medical Solutions USA, Inc. PDF, 114KB, File does not meet accessibility standards Date: 31. July 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 04458/14

Corrective action for the defibrillator-/patient monitoring system corpuls3, GS Elektromedizinische Geräte G. Stemple GmbH PDF, 341KB, File does not meet accessibility standards Date: 31. July 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 03748/14

Corrective action for the FEMTELLE® uPA/PAI-1 kit, Sekisui Diagnostics PDF, 87KB, File does not meet accessibility standards Date: 31. July 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 03086/14

Corrective action for the Guardian® REAL-Time Monitors, Medtronic PDF, 138KB, File does not meet accessibility standards Date: 31. July 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electric blood glucose meters
Reference 04289/14

Corrective action for the products LINK 4+, Link 6+, Link 8+, Fresenius Kabi Deutschland GmbH PDF, 29KB, File does not meet accessibility standards Date: 31. July 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 04116/14

Corrective action concerning the HeartSine® samaritan® PAD (public access defibrillators), HeartSine Technologies PDF, 220KB, File does not meet accessibility standards Date: 30. July 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 04022/14

Recall for the AdVance® XP Male Sling System, American Medical Systems (AMS) PDF, 212KB, File does not meet accessibility standards Date: 30. July 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 04350/14

Corrective action for the BrightView XCT Imaging System, Philips Healthcare PDF, 559KB, File does not meet accessibility standards Date: 30. July 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 03913/14

Corrective action for the diagnostic ultrasound system ProSound F75, Hitachi Aloka Medical, Ltd. PDF, 96KB, File does not meet accessibility standards Date: 29. July 2014 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 03435/14

Corrective action for LIFEPAK 1000 defibrillators, Physio-Control, Inc. PDF, 296KB, File does not meet accessibility standards Date: 29. July 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 03824/14