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  1. Technomed Europe, NCR 22-063, Disposable Subdermal Needle Electrode, Pt.Ir

    There are still products in the market that are accompanied with a version of the Instructions for use that does not have the MRI ...

    Waarschuwing | 12-09-2022

  2. FUJIFILM medwork, CAPA-2022-031, CrossSnare

    As long as the limit values are exceeded the products might pose a small potential threat to the health of users or patients ...

    Waarschuwing | 07-09-2022

  3. Biomedical Data Solutions, 73555, Ortho Connect

    When Cancelling an Edit during Result Review, Approved results are incorrectly saved using the cancelled data.  

    Waarschuwing | 07-09-2022

  4. Philips Respironics, 2022-CC-SRC-001, Amara View Minimal Contact Full-Face Mask (Full Face Mask) DreamWear Full Face Mask (Full Face Mask) DreamWisp Nasal Mask with Over the Nose Cushion (Nasal Mask) Wisp Nasal Mask (Nasal Mask) Wisp You

    Magnets with a magnetic field strength of 400 mT are used in the mask. With the exception of the devices identified in the ...

    Waarschuwing | 07-09-2022

  5. Becton Dickinson GmbH, FSN-IDS-22-4528, Sabouraud Agar with Chloramphenicol, Sabouraud Agar with Gentamicin and Chloramphenicol, Sabouraud GC Agar / BBL™ CHROMagar™ Candida Medium

    Based on customer feedback, BD has identified an outside supplier issue with this plate’s impregnated antibiotic, ...

    Waarschuwing | 06-09-2022

  6. Leica Microsystems (Schweiz) AG, FSN-CAPA-HER-MD-22-007, ARveo 8, ARveo, M530 OHX, PROvido

    During internal testing Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics ...

    Waarschuwing | 05-09-2022

  7. AAT Alber Antriebstechnik GmbH, FSN-07-22, V-MAX² P1605 Schiebe- und Bremshilfe

    From May 2021 to July 2022, motor brake units were installed in individual V-MAX² push and brake aids, some of which were not ...

    Waarschuwing | 05-09-2022

  8. Haag-Streit AG, FSN-HSC CAPA 22-04, Connector Box of lmaging Module IM 910

    De afstand tussen de ethernetpoort van de aansluitdoos (Connector Box) en de interne elektronische onderdelen is onvoldoende om ...

    Waarschuwing | 30-08-2022

  9. Maquet Cardiopulmonary GmbH, FSN-656504, HLS Set Advanced 5.0, HLS Set Advanced 7.0

    The HLS Set Advanced is intended for use in an extracorporeal circulation for cardiac support and/ or pulmonary support. Maquet ...

    Waarschuwing | 25-08-2022

  10. Siemens Healthcare GmbH, FSN-AX033/21/S (FSN/Addendum) AXIOM Sensis XP/ Sensis/ Sensis Lite/ Vibe Combo

    We would like to inform you about a potential issue with your AXIOM Sensis XP, Sensis/Sensis Lite or Sensis Vibe Combo system and ...

    Waarschuwing | 23-08-2022