Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

43 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. iMDsoft Ltd., MCR 151-2 MDSS ref. MDD23.144, MetaVision

    Bij gebruik van het bestelsjabloon met de hoeveelheid in gewichtseenheden wordt de bestel-/dosishoeveelheid berekend volgens het ...

    Waarschuwing | 12-07-2023

  2. Hamilton Bonaduz AG, FSCA-2023-01, CO-RE Tips CO-RE II Tips

    As root cause the filter has been identified. Said filter is being inserted into to the tip during production.

    Waarschuwing | 16-06-2023

  3. Boston Scientific Corporation, 97005302-FA, Watchdog Hemostasis Valve Kit

    Boston Scientific is initiating a removal of specific batches of the WATCHDOGTM Hemostasis Valve Kit due to complaints of the ...

    Waarschuwing | 17-04-2023

  4. Radiometer Medical ApS., FSN-FAN 915-424, AQURE system

    AQURE System – possible incorrect reply on patient queries from LumiraDx device. Radiometer has become aware of a potential ...

    Waarschuwing | 09-03-2023

  5. CooperSurgical tbd Sage Vitrification Media Kit

    It has come to CooperSurgical’s attention that certain SAGE Vitrification Media Kits within LOT 211112-002333 may contain ...

    Waarschuwing | 27-02-2023

  6. ALPRO MEDICAL GMBH, 3121, 3123, 3124, 3125-N, AlproCleaner

    The product recall was decided after we discovered that AlproCleaner's delivery forms were shipped with incorrect labeling. As a ...

    Waarschuwing | 21-11-2022

  7. FertiProNV, CAPA 2209-03, FertiCult Mineral Oil

    FertiPro recently received a complaint of FertiCult Mineral Oil - lot FP21FM28 about decreased embryo development rate and ...

    Waarschuwing | 04-10-2022

  8. FUJIFILM Irvine Scientific, Inc., FSN-RWN# 21001, Vitrification Freeze Kit

    Dit herziene veiligheidsbulletin dient om aanvullende informatie te verstrekken over de Vitrification Freeze Kit:...  

    Waarschuwing | 07-01-2022

  9. B Medical Systems FSCA_2021001 - Premium Line devices with FW5.8

    The customer reported that the temperature displayed by the unit was 3.9°C, while the actual air temperature inside the unit, ...

    Waarschuwing | 06-01-2022

  10. Analis FSN 210707-1 - HyPro Medical 3 procent_v4_update

    De prestatievalidatie is mislukt wat betreft de virucidale werking volgens EN14476 op het poliovirus.

    Waarschuwing | 22-12-2021