Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

249 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Richard Wolf GmbH, FSN-QM700014400, TUBE SET FOR TEM

    As a result of our continuous product surveillance we became aware of a production-related deficiency in a pump tube comprised in ...

    Waarschuwing | 05-06-2020

  2. Field Safety Notice: Abbott, Inc., HeartMate PHP™ (percutane hartpomp)

    Dit is een voorzorgsmaatregel vanwege meldingen van een gering aantal klinische voorvallen in verband met het uitvallen van de ...

    Waarschuwing | 06-02-2017

  3. Gambro Industries, FA-2022-040, Prismaflex etc

    The current Prismaflex set IFU is a single booklet containing 27 translated languages, and the following products include a ...

    Waarschuwing | 06-10-2022

  4. Baxter, FA-2022-006, PrisMax V2 ROW- V3 ROW

    Baxter Healthcare Corporation is issuing a Device Correction to the user level for the PrisMax System. This correction is due to ...

    Waarschuwing | 30-03-2022

  5. Cook Incorporated, FSN-2021FA0011, Transseptal Needle, various products

    Cook Medical has identified that the transseptal needles may contain rust on the interior and/or exterior of the needle.

    Waarschuwing | 19-10-2021

  6. Baxter Healthcare, FA-2021-047, PrisMax V2

    This correction is due to a software anomaly occurring during use.    

    Waarschuwing | 15-10-2021

  7. Gambro Lundia AB, FSN-FA-2021-005, Prismaflex Control Unit

    Healthcare Corporation is issuing a Device Correction to the user level for the Prismaflex Control Unit due.

    Waarschuwing | 01-02-2021

  8. GAMBRO DASCO, FSN-FA-2020-068, Haemodialysis tubing set single-use

    Baxter Healthcare Corporation has received customer reports of kinked access lines observed during treatment using cartridge sets ...

    Waarschuwing | 06-01-2021

  9. Maquet_Getinge FSCA-2020-12-07 - Pediatric Venous Hardshell Cardiotomy Reservoir

    During verification testing of Pediatric VKMOs and VHKs a potential impairment of the sterile packaging barrier system was ...

    Waarschuwing | 16-12-2020

  10. Maquet Critical Care AB, FSN-MCC 20 009 IU, Heart Lung Machine HL 40 occlusion clamp assembly

    This letter is to inform you that “hot swapping” the electro-mechanical venous occlusion clamp (EVOC) should be avoided while the ...

    Waarschuwing | 09-07-2020