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14,982 results

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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

Corrective action for the VERO™/MHI-TM2000 Linear Accelerator System, Mitsubishi Heavy Industries, Ltd. PDF, 3MB, File does not meet accessibility standards Date: 29. July 2014 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 03965/14

Corrective action for the KODAK DirectView DR 7500 System, Carestream Health, Inc. PDF, 21KB, File does not meet accessibility standards Date: 29. July 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 03976/14

Corrective action for the diagnostic ultrasound system ARIETTA 60 and ARIETTA 70, Hitachi Aloka Medical, Ltd. PDF, 101KB, File does not meet accessibility standards Date: 29. July 2014 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 03746/14

Corrective action for the Recipient Vacuum Trephine, Network Medical Products PDF, 354KB, File does not meet accessibility standards Date: 29. July 2014 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04300/14

Corrective action for certain care beds from Hermann Bock GmbH / Replacement of MD201 twin drives from limoss GmbH & Co. KG PDF, 195KB, File does not meet accessibility standards Date: 28. July 2014 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 03800/14

Corrective action concerning the ACL TOP Family Coagulation Systems, Instrumentation Laboratory PDF, 45KB, File does not meet accessibility standards Date: 28. July 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 03699/14

Corrective action for the ADVIA Centaur® CP, Siemens PDF, 36KB, File does not meet accessibility standards Date: 28. July 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 03728/14

Safety Notice for the PTFE Ventilation Tubes, Spiggle & Theis Medizintechnik GmbH PDF, 12MB, File does not meet accessibility standards Date: 28. July 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 03373/14

Urgent Safety Notice for the E.CAM® Patient Handling System (PHS), Siemens PDF, 483KB, File does not meet accessibility standards Date: 28. July 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 04242/14

Recall for the FOCUS Gesundheit Kinderwunsch-Test, ulti med Products (Deutschland) GmbH PDF, 213KB, File does not meet accessibility standards Date: 28. July 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 00830/13

Corrective action for PCs for use with the AU480, AU680, and PK7300 Systems (InoNet – Mayflower PC), Beckman Coulter PDF, 31KB, File does not meet accessibility standards Date: 25. July 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03943/14

Corrective action for the Oxoid Legionella BCYE Growth Supplement, Thermo Fisher Scientific PDF, 24KB, File does not meet accessibility standards Date: 25. July 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 03550/14

Urgent Safety Notice for the Application Instrument of Sternal ZipFix™, Synthes GmbH PDF, 387KB, File does not meet accessibility standards Date: 25. July 2014 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04129/14

Recall for hydrogel contact lenses, Wöhlk-Contact-Linsen GmbH PDF, 2MB, File does not meet accessibility standards Date: 25. July 2014 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - contact lenses
Reference 03655/14

Urgent Medical Device Safety Notification for the CODMAN® CERTAS™ Programmable Valves, Medos International SARL / DePuy Synthes Codman Neuro PDF, 147KB, File does not meet accessibility standards Date: 25. July 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 04228/14

Corrective action for TRIGEN INTERTAN Nails, Smith & Nephew PDF, 112KB, File does not meet accessibility standards Date: 23. July 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 03680/14

Recall for the RT-PLUS™ Modular Femoral Components due to a packaging issue, Smith & Nephew PDF, 69KB, File does not meet accessibility standards Date: 23. July 2014 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 04164/14

Corrective action for the Ascenda™ Intrathecal Catheters / Revision Kits, Medtronic PDF, 82KB, File does not meet accessibility standards Date: 22. July 2014 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - drug pumps
Reference 04023/14

Urgent Safety Notice for Sorin Heater Cooler Devices, Sorin Group Deutschland GmbH PDF, 796KB, File does not meet accessibility standards Date: 22. July 2014 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 04000/14

Recall for the product Dafilon Blue, B. Braun Surgical S.A. PDF, 3MB, File does not meet accessibility standards Date: 22. July 2014 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - surgical sutures, vascular loops etc.
Reference 04064/14

Corrective action for the products Nail Insertion Sleeve, elastic T2 Tibia SPI Ø8-11 and Nail Insertion Sleeve, elastic T2 Tibia SPI Ø8-13, Stryker Trauma GmbH PDF, 70KB, File does not meet accessibility standards Date: 22. July 2014 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04053/14