Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. FSN-PR130017, Drägerwerk AG & Co. KGaA, Oxylog 3000 plus

    During the course of our global market surveillance activities, we have become aware of instances where emergency and transport ...

    Waarschuwing | 08-06-2023

  2. FSN-2023-001, Xiros Ltd., Suture/needle passer

    Xiros has received feedback that there have been a small number of instances where the CC-Hook instrument has deformed during ...

    Waarschuwing | 08-06-2023

  3. FSN-FA 23021, Beckman Coulter, Inc., DxI 9000 Access Immunoassay Analyzer

    Beckman Coulter heeft vastgesteld dat de hierboven vermelde softwareversie van de DxI 9000 Access-immunoassay-analyser het aantal ...

    Waarschuwing | 08-06-2023

  4. FSN-CAPA-00005233 Abbott Diagnostics Technologies AS Alere Afinion 2 Afinion 2

    Abbott has identified an issue related to overheating of Afinion 2 instruments with software version ≤ 21.13. 

    Waarschuwing | 08-06-2023

  5. FSN-01/2023, EUREKA SRL LAB DIVISION, Noradrenalina IVD, calibrator and control

    A thorough examination at customer site of the calibrator performance showed that the Noradrenaline values were overestimated.  ...

    Waarschuwing | 08-06-2023

  6. FSN-PR6, Altomed Limited, Damato Ruthenium Plaque Template

    Our international distributor informed us of a complaint they received from one of their customers. The CIB template (REF  ...

    Waarschuwing | 08-06-2023

  7. FSN-CI 3028397, QIAGEN GmbH, QIAstat-Dx® Respiratory SARS-CoV-2 Panel

    Deze dringende veiligheidsmededeling dient om u erover te informeren dat QIAGEN heeft vastgesteld dat bepaalde partijen van de ...

    Waarschuwing | 08-06-2023

  8. B.Braun Melsungen AG, FSCA-2023-05-30, PROSET INTRAFIX SAFESET

    Tijdens kwaliteitsonderzoek is vastgesteld dat een deel van bovengenoemde artikel/charge combinatie mogelijk in verband kan ...

    Waarschuwing | 07-06-2023

  9. Olympus Medical Systems Corporation, QIL FY24-EMEA-03-FY23-OMTA-35-HX-202-LRUR, SINGLE USE REPOSITIONABLE CLIP HX-202LR.UR

    Olympus has become aware of increased complaints on clip deployment occurring during clinical procedures, leading to hazardous ...

    Waarschuwing | 07-06-2023

  10. Lowenstein Medical Technology GmbH Co. KG, FSN-2023-01, LM150TD

    If changes are made to the linking of accessories by changing products or adding accessories, a new circuit test is required to ...

    Waarschuwing | 07-06-2023