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Urgent Field Safety Notice for X-Change by Howmedica Osteonics Corporation PDF, 128KB, File does not meet accessibility standards Date: 27. February 2020 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 14171/19

Urgent Field Safety Notice for Monopolare Schere IN CUT; Monopolare Pinzette ENDOGRIP; Monopolare Haken ENDOHOOK by PETERS SURGICAL PDF, 193KB, File does not meet accessibility standards Date: 27. February 2020 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 00209/20

Urgent Field Safety Notice for MR-Set ELS 65ml , ELS 65ml syringe by MEDTRON AG PDF, 161KB, File does not meet accessibility standards Date: 27. February 2020 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 01973/20

Urgent Field Safety Notice for Nextra Hammertoe Correction System by Nextremity Solutions, Inc. PDF, 3MB, File does not meet accessibility standards Date: 21. February 2020 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 01952/20

Urgent Field Safety Notice for SMR Shoulder cementless finned stem L.80mm dia.19m by Lima Corporate S.p.A. PDF, 4MB, File does not meet accessibility standards Date: 21. February 2020 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 02281/20

Urgent Field Safety Notice for ETHIBOND EXCEL Polyester Suture by Ethicon, Inc. PDF, 231KB, File does not meet accessibility standards Date: 21. February 2020 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - surgical sutures, vascular loops etc.
Reference 07394/19

Urgent Field Safety Notice for Raymat AS1 by Raymed Imaging AG PDF, 71KB, File does not meet accessibility standards Date: 20. February 2020 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 02223/20

Urgent Field Safety Notice for COROFLEX ISAR NEO 2.25 X 24 MM by B. Braun Melsungen AG, Aesculap Division Vascular Systems PDF, 4MB, File does not meet accessibility standards Date: 19. February 2020 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 02234/20

Urgent Field Safety Notice for CYTOGUIDE needle guide bushes by Turon MedTech AB PDF, 5MB, File does not meet accessibility standards Date: 19. February 2020 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 01675/20

Urgent Field Safety Notice for Innex by Zimmer GmbH PDF, 13MB, File does not meet accessibility standards Date: 19. February 2020 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 02196/20

Urgent Field Safety Notice for MAGEC Spinal Bracing and Distraction System by NuVasive Specialized Orthopedics, Inc., a division of NuVasive, Inc. PDF, 679KB, File does not meet accessibility standards Date: 18. February 2020 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - others
Reference 02049/20

Urgent Field Safety Notice for ThermaCare by Pfizer Consumer Health Care PDF, 310KB, File does not meet accessibility standards Date: 18. February 2020 Topics: Medical devices Type: Customer information

Product group Physical therapy - climatotherapy
Reference 00311/20

Urgent Field Safety Notice for Artis zeego & Artis zee/Q./Q.zen by Siemens Healthcare GmbH Advanced Therapies PDF, 961KB, File does not meet accessibility standards Date: 18. February 2020 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 02050/20

Urgent Field Safety Notice for TA IQ FWD by Reha-Med Hilfsmittel GmbH PDF, 235KB, File does not meet accessibility standards Date: 18. February 2020 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 07882/19

Urgent Field Safety Notice for Bellco MICROPLAS plasmafilters by Bellco S.p.A. PDF, 297KB, File does not meet accessibility standards Date: 17. February 2020 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - therapeutic apheresis procedures
Reference 02015/20

Urgent Field Safety Notice for TriVerse electrosurgical device by Covidien llc PDF, 138KB, File does not meet accessibility standards Date: 17. February 2020 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 01880/20

Urgent Field Safety Notice for Alaris Extension Sets, Low Sorbing (PE) by Shanghai Kindly Enterprise Development Group Co Ltd PDF, 81KB, File does not meet accessibility standards Date: 14. February 2020 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 01216/20

Urgent Field Safety Notice for IMMULITE/IMMULITE 1000/IMMULITE2000/IMMULITE 2000XPi by Siemens Medical Solutions Diagnostics PDF, 98KB, File does not meet accessibility standards Date: 14. February 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 09636/19

Urgent Field Safety Notice for Hemochron Signature Elite by Accriva Diagnostics, Inc. dba as International Technidyne Corp. PDF, 2MB, File does not meet accessibility standards Date: 14. February 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 01329/20

Urgent Field Safety Notice for FilmArray Blood Culture Identification (BCID) Panel by BioFire Diagnostics, LLC PDF, 1MB, File does not meet accessibility standards Date: 14. February 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 00939/20

Urgent Field Safety Notice for Chemistry QC Premium Plus by Randox Laboratories Ltd PDF, 1MB, File does not meet accessibility standards Date: 14. February 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01872/20

Urgent Field Safety Notice for NucliSENS Lysis Buffer by bioMérieux S. (Marcy- l'Etoile) PDF, 329KB, File does not meet accessibility standards Date: 14. February 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 00280/20

Urgent Field Safety Notice for MyCare Insite Clozapine Test Kit by Saladax Biomedical, Inc. PDF, 291KB, File does not meet accessibility standards Date: 14. February 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01005/20

Urgent Field Safety Notice for MyCare Insite Clozapine Test Kit by Saladax Biomedical, Inc. PDF, 407KB, File does not meet accessibility standards Date: 14. February 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01909/20

Urgent Field Safety Notice for Rotor-Gene Q by QIAGEN GmbH PDF, 232KB, File does not meet accessibility standards Date: 14. February 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01095/20

Urgent Field Safety Notice for NycoCard D-Dimer by Abbott Diagnostics Technologies AS PDF, 130KB, File does not meet accessibility standards Date: 13. February 2020 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 16829/19

Urgent Field Safety Notice for PALAMIX UNO; PALAMIX DUO by Heraeus Medical GmbH PDF, 214KB, File does not meet accessibility standards Date: 12. February 2020 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 01086/20

Urgent Field Safety Notice for PSPIX by SOPRO PDF, 3MB, File does not meet accessibility standards Date: 12. February 2020 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for stomatological diagnostics
Reference 00589/20

Urgent Field Safety Notice for aura6000® Remote Control and Charger; 500.0100 / NA by LivaNova, Inc PDF, 3MB, File does not meet accessibility standards Date: 12. February 2020 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 00528/20

Urgent Field Safety Notice for aura6000® Remote Control and Charger; 500.0100 / NA by LivaNova, Inc PDF, 422KB, File does not meet accessibility standards Date: 12. February 2020 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 00531/20