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Urgent Field Safety Notice for 3D Optical Coherence Tomography by Topcon Corporation PDF, 2MB, File does not meet accessibility standards Date: 12. February 2019 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological diagnostics
Reference 00404/19

Urgent Field Safety Notice for PROVERT by PROTEC GmbH & Co. KG PDF, 69KB, File does not meet accessibility standards Date: 12. February 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 01126/19

Urgent Field Safety Notice for PROGNOST ES / PROGNOST FS / PROGNOST S. by PROTEC GmbH & Co. KG PDF, 69KB, File does not meet accessibility standards Date: 12. February 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 01165/19

Urgent Field Safety Notice for SAPPHIRE administration Sets by ICU Medical PDF, 389KB, File does not meet accessibility standards Date: 12. February 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 01515/19

Urgent Field Safety Notice for Endothelmikroskop I Specular Microscope CEM-530 by NIDEK CO., LTD PDF, 57KB, File does not meet accessibility standards Date: 11. February 2019 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 01446/19

Urgent Field Safety Notice for Valtitude, Resonate, Momentum, Autogen, Inogen, Visionist, Vigilant, Charisma, Dynagen, Origen by Boston Scientific Corp., Scimed PDF, 288KB, File does not meet accessibility standards Date: 11. February 2019 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - defibrillators
Reference 12792/17

Urgent Field Safety Notice for Edwards Commander Delivery System by Edwards Lifesciences LLC PDF, 320KB, File does not meet accessibility standards Date: 11. February 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 01463/19

Urgent Field Safety Notice for Monaco RTP System by IMPAC Medical Systems, Inc. PDF, 86KB, File does not meet accessibility standards Date: 08. February 2019 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 01382/19

Urgent Field Safety Notice for Valitude, Accolade, Essentio, Visionist, Proponent, Altrua 2 by Boston Scientific CRM PDF, 599KB, File does not meet accessibility standards Date: 08. February 2019 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 12800/17

Urgent Field Safety Notice for CFF05 5x75mm Kii Fios Advanced Fixation Access Sys by Applied Medical Resources PDF, 170KB, File does not meet accessibility standards Date: 07. February 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - visceral surgery
Reference 01377/19

Urgent Field Safety Notice for BonAlive putty MIS by BonAlive Biomaterials Ltd PDF, 113KB, File does not meet accessibility standards Date: 06. February 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - materials for implants
Reference 01305/19

Urgent Field Safety Notice for Patientenset für R100 by Metran Co. Ltd. PDF, 309KB, File does not meet accessibility standards Date: 06. February 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 01213/19

Urgent Field Safety Notice for GRP-Handgriff by MGB Endoskopische Geräte GmbH Berlin PDF, 91KB, File does not meet accessibility standards Date: 06. February 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 00741/19

Urgent Field Safety Notice for Padlock Clip defect closure system by United States Endoscopy Group, Inc. PDF, 8MB, File does not meet accessibility standards Date: 05. February 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 01239/19

Urgent Field Safety Notice for AXIUS Blower Mister by Maquet Cardiovascular PDF, 88KB, File does not meet accessibility standards Date: 05. February 2019 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 00978/19

Urgent Field Safety Notice for Acuson NX2 , NX2 Elite, NX3, NX3 Elite, by Siemens Medical Solutions USA, Inc. Ultrasound PDF, 552KB, File does not meet accessibility standards Date: 05. February 2019 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 01172/19

Urgent Field Safety Notice for LOGIQ P6 systems by GE Medical Systems Information Technologies GmbH PDF, 280KB, File does not meet accessibility standards Date: 05. February 2019 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 00465/19

Urgent Field Safety Notice for Broach handles for rasp used in orthopedic surgery for the implantation of by EVOLUTIS SAS PDF, 162KB, File does not meet accessibility standards Date: 04. February 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 07841/18

Urgent Field Safety Notice for Celsite Safety by B.BRAUN MEDICAL Saint Cloud PDF, 29KB, File does not meet accessibility standards Date: 01. February 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 15381/18

Urgent Field Safety Notice for Cortical Screw 3.5 by aap Implantate AG PDF, 59KB, File does not meet accessibility standards Date: 01. February 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 01093/19

Urgent Field Safety Notice for PROXIMATE® PPH Procedure for Prolapse and Hemorrhoids:; PROXIMATE® HCS Procedure for Prolapse and Hemorrhoids (PPH) by Ethicon Endo-Surgery, LLC. PDF, 347KB, File does not meet accessibility standards Date: 31. January 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 15264/18

Urgent Field Safety Notice for Oxoid BrillianceT ESBL/Brilliance CRE Bi-Plate by Thermo Fisher Scientific - Microbiology Central Reporting PDF, 248KB, File does not meet accessibility standards Date: 31. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 15779/18

Urgent Field Safety Notice for ARCHITECT Free T3 Reagent Kit and ARCHITECT Total T3 Reagent Kit by Abbott Ireland Diagnostics Division PDF, 127KB, File does not meet accessibility standards Date: 31. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 13046/18

Urgent Field Safety Notice for Software für Immunomate by Institut VirionSerion GmbH PDF, 1MB, File does not meet accessibility standards Date: 31. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 00419/19

Urgent Field Safety Notice for TGS TA EBV Contra! Set by Technogenetics s.r.l. PDF, 1MB, File does not meet accessibility standards Date: 31. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 13512/18

Urgent Field Safety Notice for VITEK 2 ID / AST Card Types by bioMérieux Inc PDF, 256KB, File does not meet accessibility standards Date: 31. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 00494/19

Urgent Field Safety Notice for Eurotrol Hemoglobin Controls by Eurotrol B.V. PDF, 64KB, File does not meet accessibility standards Date: 31. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00203/19

Urgent Field Safety Notice for TODA AMNIODIAG 5 strip and TODA AMNIODIAG 5 cassette by TODA PHARMA PDF, 225KB, File does not meet accessibility standards Date: 31. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 15075/18

Urgent Field Safety Notice for Oxoid M.I.C.E Meropenem MA0121 by Thermo Fisher Scientific Microbiology Basingstoke PDF, 312KB, File does not meet accessibility standards Date: 31. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 00180/19

Urgent Field Safety Notice for BM-Lactate by Roche Diagnostics GmbH PDF, 447KB, File does not meet accessibility standards Date: 31. January 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 15735/18