Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Abena A/S FSN 1269554 - Abena Nova with MediSens Clip

    Abena A/S experienced irregularities with the closing function of a clip. Hence, the clip was not tightening appropriately around ...

    Waarschuwing | 19-05-2020

  2. Turon MedTech AB D040307FSCA rev02 - CYTOGUIDE needle guide bushes

    Some bushings have a material defect, which makes them brittle. The degree of this material defect varies. However, some of them, ...

    Waarschuwing | 05-02-2020

  3. Getinge Disinfection AB CAPA 219071 - Getinge 88-series

    This is to inform you of a potential leakage that can occur on devices produced before November 2012. Our records indicate that ...

    Waarschuwing | 17-01-2020

  4. Luminex RC-19-012 - VERIGENE® External Barcode Scanner

    An investigation has identified that the supplier of our VERIGENE External Barcode Scanner had issues scanning barcode labels ...

    Waarschuwing | 06-12-2019

  5. Tobrix BV, Tobrix radial fiber TXMF600R

    Recentelijk zijn er een 3tal fibers met LOT nummer 1801005 defect gegaan gedurende de ELVA procedure.

    Waarschuwing | 06-06-2019

  6. FSN E-Drive - Decon Wheel AB

    Decon Wheel AB has been informed that E-Drive can be mounted incorrectly on the Etac Cross 5 wheelchair. According to the ...

    Waarschuwing | 08-11-2017

  7. BioMérieux SA, FSCA #5763-1, BK VIRUS R-GENE

    The aim of this communication is to inform you about low positive signals (aspecific signals below Ct corresponding to the limit ...

    Waarschuwing | 17-08-2023

  8. Mikrogen GmbH, M23004, recomLine HIV Rev001 Build001.stc

    Programming gap with an extremely rare band ratio of gp41 to gp36, resulting in a borderline output instead of positive, ...

    Waarschuwing | 06-03-2024

  9. Lowenstein Medical Innovation, elisa 300.500.600.800

    Door deze foutconstellatie in het buffergeheugen zijn de meeste alarmen effectief uitgeschakeld. Als een parameter wordt ...

    Waarschuwing | 04-01-2024

  10. Ecolab Deutschland GmbH, ECL-FSCA-001, Incidin OxyWipe S; Incidin OxyFoam S

    Ecolab have retested the product’s efficacy of Incidin OxyWipe S and Incidin OxyFoam S against C. difficile according to the norm ...

    Waarschuwing | 15-12-2023