Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Mevion Medical Systems FSCA_220223 - Mevion S250i

    An instance occurred at a customer site where a stuck motion button (see image below) on the Hand Pendant caused unintended Couch ...

    Waarschuwing | 10-03-2022

  2. Thermo Fisher Scientific, FSN-2022-002, ARIS HiQ

    If an ESD pulse from a build-up of static electricity is discharged on the HiQ front door it can cause the instrument to go into ...

    Waarschuwing | 04-03-2022

  3. STRYKER ENDOSCOPY, RA2022-2912780, 1688 Camera Control Unit (CCU)

    A software defect has been identified in the 1688 Camera Control Unit (CCU) that will cause the image on the monitor to flip ...

    Waarschuwing | 02-03-2022

  4. NeuMoDx Molecular, a QIAGEN Company, FSN-CA-2021-006, NeuMoDx Cartridge

    QIAGEN has become aware of the potential for false positive results to occur when the above lot of cartridges are used in ...

    Waarschuwing | 24-02-2022

  5. Mevion Medical Systems FSCA_220126 - Mevion S250i

    Mevion was informed of an instance where a user changed only the Setup isocenter in ARIA in a previously approved plan, without ...

    Waarschuwing | 24-02-2022

  6. SEBIA, FSN-FSCA-02-2022-01, CAPI 3 IMMUNOTYPING

    We inform you that a user of these kits highlighted an inversion between the anti-Ig M and anti-Lambda antisera. Our ...

    Waarschuwing | 24-02-2022

  7. Mikrogen GmbH, FSN-DE/202001, ampliCube HEV 2.0 quant

    With this letter we would like to inform you about a mistake in the instructions for use of our ampliCube HEV 2.0 Quant (Art. no. ...

    Waarschuwing | 24-02-2022

  8. Sysmex FSN524700045 - FLUOROCELL PLT

    Unfortunately it has come to our attention that Sysmex haematology IVD reagent Fluorocell PLT might show a decrease of the side ...

    Waarschuwing | 23-02-2022

  9. Sanquin Reagents FSN181410 - MabTrack level infliximab kit

    There is a small chance that your kit contains a detective microtiter plate. lf your kit contains a detective microtiter plate, ...

    Waarschuwing | 23-02-2022

  10. Drägerwerk AG & Co KGaA, FSN-PR114992, Evita V300; Evita V500; Babylog VN500

    The abovementioned ventilators use specially hardened operating systems. However, one of the used operating systems cannot be ...

    Waarschuwing | 22-02-2022