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Urgent Field Safety Notice for IGG-2 by Roche Diagnostics GmbH PDF, 536KB, File does not meet accessibility standards Date: 27. September 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 11754/19

Urgent Field Safety Notice for MYO2 (Tina-quant Myoglobin Gen.2) by Roche Diagnostics GmbH PDF, 300KB, File does not meet accessibility standards Date: 27. September 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 08178/19

Urgent Field Safety Notice for IH-1000 Analyzer by Bio-Rad Laboratories, DiaMed GmbH PDF, 4MB, File does not meet accessibility standards Date: 27. September 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 11232/19

Urgent Field Safety Notice for MOSAIQ by IMPAC Medical Systems, Inc. PDF, 57KB, File does not meet accessibility standards Date: 27. September 2019 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 12766/19

Urgent Field Safety Notice for S4C OCCIPITAL PLATE SMALL 5 HOLES by Aesculap AG PDF, 258KB, File does not meet accessibility standards Date: 27. September 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 12834/19

Urgent Field Safety Notice for Various Biomet Products by Biomet Orthopedics, LLC PDF, 234KB, File does not meet accessibility standards Date: 27. September 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 12751/19

Urgent Field Safety Notice for SOMATOM CT scanner, several types by Siemens Healthcare GmbH Computed Tomography (CT) PDF, 6MB, File does not meet accessibility standards Date: 27. September 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 12781/19

Urgent Field Safety Notice for Adult/Small Adult Venous Hardshell Cardiotomy Reservoir (VHK) and combination of reservoir with oxygenator (VKMO(D)) by Maquet Cardiopulmonary GmbH PDF, 3MB, File does not meet accessibility standards Date: 27. September 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 12181/19

Urgent Field Safety Notice for MONOPLUS VIOLET 0(3,5)150CM HR48 LOOP(M) DDP by B. Braun Surgical S.A. PDF, 730KB, File does not meet accessibility standards Date: 26. September 2019 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - surgical sutures, vascular loops etc.
Reference 11871/19

Urgent Field Safety Notice for EO-150 Ventilator by EOVE PDF, 176KB, File does not meet accessibility standards Date: 26. September 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 11719/19

Urgent Field Safety Notice for Heater Unit HU35 by Maquet Cardiopulmonary AG PDF, 3MB, File does not meet accessibility standards Date: 25. September 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 10365/19

Urgent Field Safety Notice for Chartr EP 200 by Natus Medical Denmark going on the market under GN Otometrics A/S brand name PDF, 257KB, File does not meet accessibility standards Date: 25. September 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - ENT equipment
Reference 08139/19

Urgent Field Safety Notice for Embryology Heated Plate within the RI Witness by Cooper Surgical Inc. PDF, 255KB, File does not meet accessibility standards Date: 25. September 2019 Topics: Medical devices Type: Customer information

Product group In vitro fertilization - others
Reference 12677/19

Urgent Field Safety Notice for Embryology Heated Plate within the RI WitnessTM by Cooper Surgical Inc. PDF, 255KB, File does not meet accessibility standards Date: 24. September 2019 Topics: Medical devices Type: Customer information

Product group In vitro fertilization - others
Reference 12677/19

Urgent Field Safety Notice for Dario-Blood Glucose Tracker (Android Application) by LabStyle Innovations, Ltd PDF, 138KB, File does not meet accessibility standards Date: 24. September 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electric blood glucose meters
Reference 12173/19

Urgent Field Safety Notice for GCS by PAJUNK GmbH Medizintechnologie PDF, 858KB, File does not meet accessibility standards Date: 24. September 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 11578/19

Urgent Field Safety Notice for MSI Biopsieinstrument by adeor Medical AG Unterhaching PDF, 127KB, File does not meet accessibility standards Date: 23. September 2019 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 10785/19

Urgent Field Safety Notice for iLab Polaris Multi-Modality Guidance System by Boston Scientific Corporation Marlborough PDF, 517KB, File does not meet accessibility standards Date: 23. September 2019 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 12555/19

Urgent Field Safety Notice for Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series Implantable Pulse Generators (IPG) by Medtronic Inc PDF, 741KB, File does not meet accessibility standards Date: 23. September 2019 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 00659/19

Urgent Field Safety Notice for Rusch TracFlex Plus Phonation Set, Cuffed; Rusch TracFlex Plus Set, cuffed; TracFlex Plus PDT Set; Ruschcare TracFlex Plus Phonation Set, Cuffed by Teleflex (Perak West Malaysia) PDF, 154KB, File does not meet accessibility standards Date: 20. September 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 12527/19

Urgent Field Safety Notice for Patientenkabel, D by Medset Medizintechnik GmbH PDF, 746KB, File does not meet accessibility standards Date: 20. September 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 12211/19

Urgent Field Safety Notice for INNOTERE Paste-CPC, 3ml by InnoTERE GmbH PDF, 2MB, File does not meet accessibility standards Date: 19. September 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - materials for implants
Reference 11993/19

Urgent Field Safety Notice for RT-PLUS MODULAR FEMORAL BLOCK by Smith & Nephew Orthopaedics AG PDF, 318KB, File does not meet accessibility standards Date: 19. September 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 12465/19

Urgent Field Safety Notice for EYEJET CTR by Morcher GmbH PDF, 3MB, File does not meet accessibility standards Date: 19. September 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 07583/19

Urgent Field Safety Notice for DispoGrip by Teleflex Medical USA PDF, 193KB, File does not meet accessibility standards Date: 19. September 2019 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 11946/19

Urgent Field Safety Notice for BVM RESUSCITATOR ADULT 1.5L BAG SIZE 3 & 5 MASK by Intersurgical Ltd. PDF, 305KB, File does not meet accessibility standards Date: 19. September 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 10635/19

Urgent Field Safety Notice for Zenith Branch Endovascular Graft Iliac Bifurcation by William A Cook Australia Pty Ltd PDF, 273KB, File does not meet accessibility standards Date: 18. September 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 11396/19

Urgent Field Safety Notice for Medline Sterile Absorbent Cotton O.R Towels by ArcRoyal Ltd. PDF, 1MB, File does not meet accessibility standards Date: 18. September 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 12371/19

Urgent Field Safety Notice for Warming Solution Set 205, Warming Kit 102, Vitrification Solution Set 110, Vitrification Kit 101 by REPROLIFE PDF, 627KB, File does not meet accessibility standards Date: 18. September 2019 Topics: Medical devices Type: Customer information

Product group In vitro fertilization - others
Reference 06989/19

Urgent Field Safety Notice for Easyret by QUANTEL M EDICAL PDF, 854KB, File does not meet accessibility standards Date: 17. September 2019 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 10436/19