Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Tcoag Ireland Ltd, FSN-Event-2244, Destiny Max, DT 100

    This Field Safety Notice (FSN) is about a potential risk of contamination by Emicizumab - of Factor VIII assays on the Tcoag DT ...

    Waarschuwing | 13-01-2021

  2. NuVasive, Inc., FSN-MAGEC-3, MAGEC System

    NuVasive, Inc. geeft deze veiligheidsmededeling uit om zorgverleners in de Europese Unie informatie te verschaffen over de MAGEC® ...

    Waarschuwing | 12-01-2021

  3. GE Medical Systems LLC, FSN-FMI 25496, Revolution Apex Revolution CT

    Mogelijke rijtwonden door scherpe randen van blootliggende tafelschroef op Revolution Apex, Revolution CT met Apex-editie, ...

    Waarschuwing | 11-01-2021

  4. Baxter Healthcare SA, FSN-FA-2020-065, PRISMAX, V2 ROW

    Baxter Healthcare Corporation is issuing a Device Correction for the PrisMax System due to inconsistent variability of the tubing ...

    Waarschuwing | 11-01-2021

  5. Baxter Healthcare SA, FSN-FA-2020-064, PrisMax, V2, ROW

    Baxter Healthcare is issuing a Safety Alert for the PrisMax System.

    Waarschuwing | 11-01-2021

  6. Olympus Medical Systems Corporation, FSN-QIL 153-014, Certain Olympus Endotherapy Products

    RECALL OF CERTAIN OLYMPUS ENDOTHERAPY PRODUCTS DUE TO THE INTEGRITY OF STERILE PACKAGING.

    Waarschuwing | 08-01-2021

  7. Dexcom, Inc., FSN-Dexcom ref. FAS-SD-20-003; MDSS ref. MDD20.347, Dexcom G6 sensor

    This field safety notice applies to Dexcom G6 Sensor Models STS-GS-002 and STS-GS-003.

    Waarschuwing | 08-01-2021

  8. Olympus Medical Systems Corporation, FSN-QIL 153-015, GASTROINTESTINAL VIDEOSCOPE / COLONOVIDEOSCOPE

    URGENT FIELD SAFETY NOTICE QUARANTINE OF THE EZ1500 SERIES ENDOSCOPES.

    Waarschuwing | 08-01-2021

  9. 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

  10. Young Innovations FSCA_2020_001 - (Adapters for) Air_Water Syringe Tips

    There is no product safety problem. Between October 30 2019 and May 27 2020 products were supplied with incorrect details of the ...

    Waarschuwing | 04-01-2021