Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Sunrise Medical GmbH, FSN-07200100/84600000, Easy Life & Easy Life T

    Veiligheidsinspectie Quickie Life en Life T hulpmiddel

    Waarschuwing | 28-04-2020

  2. AngioDynamics Inc, FSN-1319211-04-24-2020-001-R, NanoKnife Single Electrode Probe

    NanoKnife Single Electrode Probe

    Waarschuwing | 28-04-2020

  3. Abbott GmbH, FSN-FA24APR2020, ARCHITECT iGentamicin Reagent Kit

    This letter is to inform you of a Product Correction for the ARCHITECT iGentamicin assay.

    Waarschuwing | 27-04-2020

  4. GAMBRO DASCO, FSN-FA-2020-020, ARTISET HD SN HC, CARTRIDGE SINGLE NEEDLE, ULTRA HDF LINE, ARTISET HD DNL HC and ARTISET PREPOST

    Baxter Healthcare Corporation has received customer complaints of various disconnection events with Artiset blood tubing sets ...

    Waarschuwing | 27-04-2020

  5. DeVilbiss Healthcare DV-2020-001- DeVilbiss Compact 5 Oxygen concentrator 525KS

    Drive DeVilbiss Healthcare has received reports of a thermal event on a very small number of power line cords. Per our vigilance ...

    Waarschuwing | 24-04-2020

  6. Medtronic MiniMed FA911 Medtronic MiniMed Implantable Pump

    Routine testing is performed on samples of the MiniMed™ Implantable Pump (MIP) as part of the manufacturing process to ensure the ...

    Waarschuwing | 24-04-2020

  7. Philips Medical Systems FSCA 86100213A-IR HeartStart XL Defibrillator Monitor

    De draaischakelaar voor therapieselectie ( Energieniveauselectieknop) van de Philips HeartStart XL-defibrillator/-monitor ...

    Waarschuwing | 24-04-2020

  8. Philips Medical Systems FSCA 86100197A-IR Internal Sterilizable Defibrillator paddles

    Interne paddles kunnen na verloop van tijd slijten en zijn mogelijk niet veilig of gereed voor gebruik, tenzij de aanwijzingen in ...

    Waarschuwing | 24-04-2020

  9. GE Healthcare Datex-Ohmeda, Inc FMI 32075 Giraffe Shuttle

    GE Healthcare has become aware that when the Giraffe Shuttle is being charged the batteries could potentially emit low ...

    Waarschuwing | 24-04-2020

  10. Radiometer Medical ApS FAN 915-411 ABL80 FLEX CO-OX

    Radiometer has become aware that the internal barcode reader, included in all versions of the ABL80 analyzer, may potentially ...

    Waarschuwing | 23-04-2020