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Urgent field safety notice for NX image processing software, Agfa HealthCare N.V. PDF, 124KB, File does not meet accessibility standards Date: 21. December 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 11382/16

Urgent field safety notice for Monaco® RTP System, ELEKTA AB PDF, 153KB, File does not meet accessibility standards Date: 21. December 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 11309/16

Urgent field safety notice for CARAT I pro and CARAT II pro Ventilators, Hoffrichter GmbH PDF, 272KB, File does not meet accessibility standards Date: 21. December 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 08594/16

Lot recall of Imager II Angiographic Catheter, Boston Scientific International S.A. PDF, 624KB, File does not meet accessibility standards Date: 21. December 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 11323/16

Lot recall of RIA Tube Assembly, for RIA Drive Shaft minimum length 520 mm, for No. 314.743, sterile, DePuy Synthes PDF, 44KB, File does not meet accessibility standards Date: 21. December 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 11353/16

Lot recall of ARCHITECT Active-B12 Reagent Kit, Abbott PDF, 26KB, File does not meet accessibility standards Date: 21. December 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10481/16

Urgent field safety notice for ORTHO VISION® Analyzers with software version 3.6.0 and below, Ortho-Clinical Diagnostics PDF, 827KB, File does not meet accessibility standards Date: 21. December 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10546/16

Urgent field safety notice for Human Milk Analyser, MIRIS AB PDF, 138KB, File does not meet accessibility standards Date: 20. December 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 05011/16

Urgent field safety notice for PreciControl Varia, Level 2 - Elecsys® PTH assay on Elecsys® 2010 / cobas e 411, Roche Diagnostics GmbH PDF, 150KB, File does not meet accessibility standards Date: 20. December 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01724/16

Urgent field safety notice for QuikRead FOB Sampling-Set / QuikRead FOB quantitativ-Kit and QuikRead go iFOBT-Kit, Orion Diagnostika PDF, 97KB, File does not meet accessibility standards Date: 20. December 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 10737/16

Urgent field safety notice for Source Administration Sets (SAS) used with the Medrad® Intego PET Infusion System (Catalog Number INT CSS), Bayer Medical Care Inc. PDF, 102KB, File does not meet accessibility standards Date: 19. December 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 09575/16

Lot recall of position headed reamer scaled D8.0mm, Aesculap AG PDF, 59KB, File does not meet accessibility standards Date: 19. December 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 11217/16

Recall of Inpactor for PFNA Blade, DePuy Synthes PDF, 87KB, File does not meet accessibility standards Date: 19. December 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 11203/16

Lot recall of Screwdriver handle/ T-shape/ cannulated, Zimmer Biomet PDF, 190KB, File does not meet accessibility standards Date: 19. December 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 11202/16

Lot recall of K-wire Ø1,2 mm L100 mm trocar tip non-sterile, Biotech Ortho / Wright PDF, 164KB, File does not meet accessibility standards Date: 16. December 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 10411/16

Urgent field safety notice for instruments and containers: Java pedicle screw system / Fidji cervical / lumbar cage / Wallis posterior dynamic stabilization system, Zimmer Biomet PDF, 514KB, File does not meet accessibility standards Date: 16. December 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 08875/16

Urgent field safety notice for Oxylog 3000 / plus, Drägerwerk AG & Co. KGaA PDF, 184KB, File does not meet accessibility standards Date: 15. December 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 10717/16

Recall of Arthrex S3 Arm Sleeve Connector, Allen Medical / Hill-Rom SAS PDF, 169KB, File does not meet accessibility standards Date: 15. December 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 11081/16

Urgent field safey notice for Atrium Ocean / Oasis / Express / Express Mini chest drainage products, Maquet Getinge Group PDF, 148KB, File does not meet accessibility standards Date: 15. December 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - drainages and suction systems
Reference 10935/16

Batch recall of NewBreez intralaryngeal prosthesis, PROTiP Medical PDF, 108KB, File does not meet accessibility standards Date: 15. December 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 10585/16