Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

152 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. GA Health Company Limited, FSN-QA-FSCA-2020-0001, Andorate® / PEXTAX Disposable Endoscope Valves Set (GAR004)

    GA Health Company Ltd. became aware that suction valve from Andorate® disposable endoscope valves set was sticky and/or broken ...

    Waarschuwing | 06-11-2020

  2. Mölnlycke Health Care AB, FSN-2020-09 (01), Mölnlycke® Procedure Trays & Single Packed Shielded Bladed Trocars

    Mölnlycke has become aware of situations where the protective flanges come away from trocar cannula.

    Waarschuwing | 19-10-2020

  3. Mölnlycke Health Care AB, FSN-2020-09 (02), TUR tray

    Mölnlycke has identified a potential safety issue. During a regular inspection, a fault in the sealing machine was identified.

    Waarschuwing | 19-10-2020

  4. Mauna Kea Technologies, FSN-UA 20-001, CystoFlex UHD R

    Mauna Kea Technologies communicates this safety notice concerning the medical device confocalnminiprobe™: CystoFlex™ UHD R.

    Waarschuwing | 16-10-2020

  5. KARL STORZ SE & Co. KG, FSN-20082557, KARL STORZ OR1 FUSION CONTROL

    Actualisering apparaatsoftware en aanbevolen dringende maatregelen betreffende WO300 OR1 FUSION CONTROL® .

    Waarschuwing | 29-09-2020

  6. FUJIFILM Corporation, FSN-ECN-G1717, FUJIFILM 580-U Series and 700 Series

    FUJIFILM geeft dit Veiligheidsbulletin uit voor de endoscopen van het type EG-760R, EG-760Z, EC-760R-V/M, EC-760R-V/I, ...

    Waarschuwing | 24-09-2020

  7. Olympus Medical Systems Corporation, FSN-QIL 153-011, EVIS EXERA II & EVIS EXERA Bronchovideoscope

    Olympus Medical Systems Corporation (“Olympus”) is writing to remind you of important reprocessing instructions for the EVIS ...

    Waarschuwing | 17-09-2020

  8. Boston Scientific Corporation, FSN-92583333-FA, Hurricane RX Biliary Balloon Dilatation Catheter

    Boston Scientific Corporation (BSC) start de terugroepactie van specifieke lots/batches van Hurricane™ RX biliaire ...

    Waarschuwing | 16-09-2020

  9. Andreas Fahl Medizintechnik-Vertrieb GmbH, Inc, FSN-REF 46830, HUMIDOBAC® HME sterile

    Die Andreas Fahl Medizintechnik - Vertrieb GmbH carries out a preventive product recall of the mentioned medical devices.

    Waarschuwing | 16-09-2020

  10. Coloplast A/S, FSN-FSCA_Elefant_20200903, ELEFANT® Suction/irigation device

    Urgent Field Safety Notice ELEFANT® SUCTION/IRRIGATION DEVICE for Specific lots.

    Waarschuwing | 15-09-2020