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14,972 results

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Corrective action for the Supplementary Reagents for CFT (Sheep Blood), Siemens Healthcare Diagnostics PDF, 629KB, File does not meet accessibility standards Date: 20. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05407/15

Further Safety Information regarding Dade® Actin® Activated Cephaloplastin Reagent, Siemens Healthcare Diagnostics PDF, 30KB, File does not meet accessibility standards Date: 20. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 01506/15

Corrective action for the Philips Ingenuity TF PET/MR system, Philips Healthcare PDF, 178KB, File does not meet accessibility standards Date: 20. August 2015 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 05363/15

Corrective action for the Allura Xper Systems (Monitor Ceiling Suspension), Philips Healthcare PDF, 334KB, File does not meet accessibility standards Date: 19. August 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 05387/15

Corrective action for the Leica ASP6025 Tissue Processor, Leica Biosystems Nussloch GmbH PDF, 1MB, File does not meet accessibility standards Date: 19. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 04929/15

Corrective action for the 5.5-50 mm Continuous Radius Rods, X-spine Systems, Inc. PDF, 1MB, File does not meet accessibility standards Date: 19. August 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 02142/15

Recall for the Wrap for Medullary Nails, Synthes GmbH PDF, 2MB, File does not meet accessibility standards Date: 19. August 2015 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 04855/15

Recall for the product "Proximal Lighting Insert", Richard Wolf GmbH PDF, 4MB, File does not meet accessibility standards Date: 18. August 2015 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 04907/15

Safety Notice for the Digital Linear Accelerators/Update for the syngo RT Therapist™ software and the Control Console software, Siemens AG PDF, 26KB, File does not meet accessibility standards Date: 18. August 2015 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 05182/15

Corrective action for the DRX Evolution Systems w/Premium and Full Featured Wall stands, Carestream Health, Inc. PDF, 33KB, File does not meet accessibility standards Date: 18. August 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 04865/15

Urgent Safety Notice for the DigitalDiagnost 4.1/4.1.1, Philips Medical Systems PDF, 20KB, File does not meet accessibility standards Date: 18. August 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 05183/15

Urgent Safety Notice for the wheelchair Quickie Jive UP, Sunrise Medical PDF, 403KB, File does not meet accessibility standards Date: 18. August 2015 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 03712/15

Corrective action for the ADVIA Centaur Systems Folate Ascorbic Acid/Ascorbic Acid Diluent, Siemens Healthcare Diagnostics PDF, 27KB, File does not meet accessibility standards Date: 17. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05210/15

Corrective action for Dimension Vista® Creatinine (CREA), Siemens Healthcare Diagnostics PDF, 42KB, File does not meet accessibility standards Date: 17. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04663/15

Recall NEFA FS, DiaSys Diagnostic Systems GmbH PDF, 2MB, File does not meet accessibility standards Date: 17. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05189/15

De Puy Synthes: Recall for the Socket hexagonal, Ø 4.0/11.0 mm, cannulated PDF, 3MB, File does not meet accessibility standards Date: 17. August 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 05358/15

Recall for the Insufflation hose, silicone, XION GmbH PDF, 306KB, File does not meet accessibility standards Date: 17. August 2015 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 05355/15

Recall for the VEPTR® Caudal Rib Supports (Rib-to-Rib Construct only), Synthes GmbH PDF, 4MB, File does not meet accessibility standards Date: 17. August 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 04930/15

Recall for the product Hyperventilation mask, Yuyao Shengchang Medical Instrument Factory PDF, 8KB, File does not meet accessibility standards Date: 17. August 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 02676/15

Corrective action for the Sapphire Infusion Pump, Q Core Medical PDF, 120KB, File does not meet accessibility standards Date: 17. August 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 05004/15

Notes on XSD use PDF, 99KB, File is accessible Date: 13. August 2015 Topics: Medical devices Type: Download

Notes on the use of the XSD's

Corrective action for the Pioneer® Plus Catheter, Volcano Corporation PDF, 87KB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 04858/15

Corrective action for the Access Thyroglobulin Reagent Kit, Beckman Coulter PDF, 31KB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04955/15

Urgent Safety Notice for the TraumaDiagnost systems, Philips Medical Systems PDF, 20KB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 05101/15

Recall for AngioJet® Thrombectomy Sets, Boston Scientific International S.A. PDF, 161KB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 05074/15

Corrective action for the TRIGEN 8/7 mm x 24 cm Humeral Nail, Smith & Nephew Inc. PDF, 79KB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05086/15

Recall for the product HQD Flow Probe, Transonic Systems, Inc. PDF, 1MB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 04702/15

Updated Safety Information concerning NDI Disposable Reflective Marker Sphere, Northern Digital Inc. PDF, 372KB, File does not meet accessibility standards Date: 13. August 2015 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - cardiac/thorax surgery
Reference 04089/15

Notes PDF, 225KB, File is accessible Date: 13. August 2015 Topics: Medical devices Type: Download

Incidents and FSCA: Notes on how to use the new electronic report form

Notes PDF, 405KB, File is accessible Date: 13. August 2015 Topics: Medical devices Type: Download

Information regarding the electronic SAE report form