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  1. Lowenstein Medical Technology GmbH, LM150TD

    In rare cases, an internal communication problem between the ventilator's controllers may result in ventilation being ...

    Waarschuwing | 03-01-2024

  2. B.Braun Melsungen AG, Introducer Needle

    Tijdens activiteiten voor postmarkttoezicht en onze interne kwaliteitscontroles hebben we vastgesteld dat bij de vermelde ...

    Waarschuwing | 03-01-2024

  3. LifeGlobal Group, 1216677-11.30.2023-001-R, global Medium

    CooperSurgical has become aware of a sudden increase in complaints regarding the aforementioned lots of this product. While we do ...

    Waarschuwing | 28-12-2023

  4. Olympus Medical Systems Corporation, Single Use Distal Cover

    Olympus has become aware that the Single Use Distal Cover MAJ-2315  may unexpectedly detach from the duodenoscope during use.

    Waarschuwing | 27-12-2023

  5. FUJIFILM medwork GmbH, Polypektomy snare

    In some cases, at specific lots of artlcle POL-X1-10-23-220-OL (Polypektomy snares) the components were connected incorrectly ...

    Waarschuwing | 27-12-2023

  6. Samsung Electronics Co, FSCA-GM85.231117-1, GM85

    Tijdens een bemonsteringsinspectie van GM85 -systemen werd Samsung Electronics zich ervan bewust dat tijdens de productiefase van ...

    Waarschuwing | 27-12-2023

  7. Ambu A.S, Ambu2023FA00002, Ambu aView 2 Advance

    Ambu has received information on two incidents where Ambu® aView™ 2 Advance caught fire when mounted on the VESA holder of the ...

    Waarschuwing | 27-12-2023

  8. Roche Molecular Systems, Inc., select Roche assays used on the cobas 5800.6800.8800 systems

    The CAPA investigation determined that the root cause of the issue is the influenza A target design of the assay, which was not ...

    Waarschuwing | 27-12-2023

  9. Medtronic, FA1324, Neuroscience CST StealthStation S7 Cranial Software v3.1.4

    Medtronic identified two software anomalies in StealthStation™ Cranial Version 3.1.4 software that can occur under specific ...

    Waarschuwing | 21-12-2023

  10. Medex, FSCA 23024, Secufill

    Some particulates have the potential to detach from the device and, in rare circumstances, might enter the fluid path and be ...

    Waarschuwing | 20-12-2023