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Urgent field safety notice for HEALAFLOW, APTISSEN S.A. PDF, 180KB, File does not meet accessibility standards Date: 11. July 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 05603/16

Recall of PHIL (Precipitating Embolic Injectable liquid) Non-Adhesive Liquid Embolic System), MicroVention Europe S.A.R.L. PDF, 78KB, File does not meet accessibility standards Date: 11. July 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 05365/16

Urgent field safety notice for Ultrastop pro med., MoNo chem-pharm Produkte GmbH PDF, 251KB, File does not meet accessibility standards Date: 11. July 2016 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 05632/16

Urgent field safety notice for Natal Care ST-LX incubator, Medix I.C.S.A. PDF, 111KB, File does not meet accessibility standards Date: 11. July 2016 Topics: Medical devices Type: Customer information

Product group Physical therapy - climatotherapy
Reference 04677/16

Urgent field safety notice for Natal Care ST-LX incubator, Medix I.C.S.A. PDF, 113KB, File does not meet accessibility standards Date: 11. July 2016 Topics: Medical devices Type: Customer information

Product group Physical therapy - climatotherapy
Reference 04676/16

Urgent field safety notice for Columbia III Agar with 5 % Sheep Blood, BD Biosciences / BD Diagnostic Systems Europe / EMA PDF, 31KB, File does not meet accessibility standards Date: 11. July 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05193/16

Urgent field safety notice for DANUBE HP supply system, Air Liquide Medical Systems PDF, 121KB, File does not meet accessibility standards Date: 08. July 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 04552/16

Lot recall of Avenir Müller Stem 6 Lateral uncemented and Avenir Müller Stem 4 Standard uncemented, Zimmer Biomet / Zimmer GmbH PDF, 408KB, File does not meet accessibility standards Date: 08. July 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05661/16

Lot recall of CORE Suction Irrigation Handpieces, CONMED Corporation PDF, 90KB, File does not meet accessibility standards Date: 07. July 2016 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 05349/16

Urgent field safety notice for MX 16-slice computed tomography x-ray system, Philips Healthcare IS China PDF, 145KB, File does not meet accessibility standards Date: 07. July 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 04974/16

Urgent field safety notice for Surgical microscope HS Hi-R 1000 and HS Hi-R 700 in combination with navigation systems, MÖLLER-WEDEL GmbH & Co. KG PDF, 264KB, File does not meet accessibility standards Date: 07. July 2016 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 05569/16

Urgent field safety notice for Homepump C‐Series Silicone Elastomeric Pumps (non‐DEHP), Halyard Health PDF, 116KB, File does not meet accessibility standards Date: 07. July 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 04476/16

Lot recall of CELL-DYN Emerald Cleaner, Abbott PDF, 71KB, File does not meet accessibility standards Date: 07. July 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05464/16

Urgent field safety notice for Guide Sleeve yellow for TFNA, Synthes GmbH / DePuy Synthes PDF, 142KB, File does not meet accessibility standards Date: 06. July 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 05531/16

Recall of Trident Constrained Liner Impactor Tips, Stryker Orthopaedics PDF, 144KB, File does not meet accessibility standards Date: 06. July 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 05487/16

Batch recall of Perfusor Line, B. Braun Melsungen AG PDF, 40KB, File does not meet accessibility standards Date: 06. July 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 05601/16

Urgent Field Safety Notice for Eye Station and Eye Care PACS, Merge Healthcare PDF, 130KB, File does not meet accessibility standards Date: 06. July 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 05485/16

Urgent field safety notice for RayStation 3.0 / 3.5 / 4.0 / 4.5 / 4.7 / 5, RaySearch Laboratories AB PDF, 494KB, File does not meet accessibility standards Date: 06. July 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 05526/16

Lot recall of HTR (Hard Tissue Replacement) Polymer Implants, Zimmer Biomet / Biomet Microfixation PDF, 90KB, File does not meet accessibility standards Date: 06. July 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05369/16

Urgent field safety notice for TrueBeam Radiotherapy Delivery System with AlignRT, Vision RT PDF, 386KB, File does not meet accessibility standards Date: 06. July 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 05542/16

Urgent field safety notice for Stratus CS / CS 200 Acute Care Diagnostics System, Siemens Healthcare Diagnostics Inc. PDF, 26KB, File does not meet accessibility standards Date: 05. July 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 05570/16

Recall of ACHILLON minimally invasive Achilles tendon suture system, NEWDEAL SAS / lntegra LifeSciences PDF, 232KB, File does not meet accessibility standards Date: 05. July 2016 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - surgical sutures, vascular loops etc.
Reference 05348/16

Urgent field safety notice for disposable fiber optic blade Miller type (single packages), W. Droh GmbH PDF, 130KB, File does not meet accessibility standards Date: 05. July 2016 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 04265/16

Urgent field safety notice for TAPERLOC HIP LATERALISED PC STEM 15.0 / 17.5 mm 12/14 Taper, Biomet UK Ltd. / Zimmer Biomet PDF, 179KB, File does not meet accessibility standards Date: 05. July 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 05359/16

Urgent field safety notice for Progressa Bed System with European (OIML) Version Scale, Hill-Rom PDF, 619KB, File does not meet accessibility standards Date: 05. July 2016 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 05546/16

Urgent field safety notice for DBS Pocket Adaptor Models 64001 and 64002, Medtronic PDF, 152KB, File does not meet accessibility standards Date: 05. July 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 05297/16

Batch recall of SAFIL QUI+ UNDY 5/0 (1) 45 cm DSMP13, B. Braun Surgical S.A. PDF, 231KB, File does not meet accessibility standards Date: 05. July 2016 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - surgical sutures, vascular loops etc.
Reference 05350/16

Urgent field safety notice for multifunctional bed XRCISE STRESS ECHO MED, ERGO-FIT GmbH & Co. KG PDF, 281KB, File does not meet accessibility standards Date: 05. July 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - functional diagnostics by way of gas exchange and exercise
Reference 05308/16

Recall of lnnocor Pulmonary function test device, INNOVISION ApS / Medset Medizintechnik GmbH PDF, 99KB, File does not meet accessibility standards Date: 01. July 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 04207/16