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  1. lmmunotech S.A.S. - A Beckman Coulter Company, 23043, Access hsTnI Reagent

    Beckman Coulter heeft vastgesteld dat er na de upgrade naar systeemsoftware 7.0.0 en hoger een restrisico op intratestoverdracht ...

    Waarschuwing | 05-10-2023

  2. Medeco B.V., FSN2023-01, Klinion Kliniray (Abdominal) Gauze Compress X-Ray

    After assessment of these products, it became known that x-ray threads in gauze compresses can disintegrate. It has been ...

    Waarschuwing | 05-10-2023

  3. TRUMPF Medizin Systeme GmbH Co. KG, FA-2023-047

    The potential impact for the missing IFU is that the users will not have awareness of appropriate use of the accessories, or ...

    Waarschuwing | 04-10-2023

  4. Covidien llc, FA1370, McGrath MAC Video Laryngoscope

    Medtronic is issuing this notification to inform the public of stolen defective  McGRATH™ MAC video laryngoscopes that have been ...

    Waarschuwing | 04-10-2023

  5. Seffiline S.R.L., SEFFIHAIR 3.1-SEFFICARE 3.1-SEFFIGYN 3.1-SEFFILLER 3.1 Seffiline S.r.l.

    During the assembly of the kits, two transfers for luerlock syringes supplied by a supplier other than the one qualified by ...

    Waarschuwing | 03-10-2023

  6. Atrium Medical Corporation, 3011175548-08.18.2023-001-C, Atrium Ocean Water Seal Chest Drains

    The Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution ...

    Waarschuwing | 03-10-2023

  7. Masimo Corporation, TC-I Reusable Tip Clip Sensor; MDSS ref: MDD23.148, TC-I Reusable Tip Clip Sensor

    Masimo identified TC- I Reusable Tip Clip sensors with higher than expected variability in SpO2 readings that are outside of the ...

    Waarschuwing | 03-10-2023

  8. MAQUET Cardiovascular, LLC, 2242352-09/06/2023-004-R, MAQUET ACROBAT-i Vacuum Stabilizer System

    Maquet/Getinge is initiating a voluntary Medical Device Removal for the Acrobat-i Vacuum Stabilizer System due to a risk of the ...

    Waarschuwing | 03-10-2023

  9. Fresenius Medical Care AG & Co. KGaA, SO-2023-3858, stay safe Disinfection Cap

    Fresenius Medical Care werkt de etikettering van onze stay-safe desinfectiekap bij. Tot de bijgewerkte etiketten behoren extra ...

    Waarschuwing | 03-10-2023

  10. GE Healthcare Finland Oy, FMI 36160, Frame F2-01

    GE HealthCare is op de hoogte van een mogelijke onderbreking in de datacommunicatie tussen de E-modules die in het F2-01 frame ...

    Waarschuwing | 03-10-2023