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  1. Draeger Medical Systems Inc., PR132825, Babyroo TN300

    During the course of our global market surveillance activities, we have become aware that the TN300 Babyroo Radiant Warmer ...

    Waarschuwing | 14-08-2023

  2. Medion Grifols Diagnostics AG, 800012088, Screen-Cyte 0.8%

    During our routine vigilance process, it has been detected that a small subset of kits (13 kits in total} of the three-cell ...

    Waarschuwing | 14-08-2023

  3. Olympus Medical Systems Corporation, Disposale EMR Kit

    Since Olympus has confirmed that alternative products can be provided, Olympus has decided to ask our customers to cease using ...

    Waarschuwing | 14-08-2023

  4. Hamilton Medical AG, HAMILTON-C1 HAMILTON-T1 HAMILTON-C2 HAMILTON-C3

    We have become aware of a malfunction with our HAMILTON-C2/C3/C1/T1 ventilators when used long term in neonatal patient group.

    Waarschuwing | 14-08-2023

  5. Dragerwerk AG en Co. KGaA, PR132399, HME TwinStar Plus and corresponding sets

    The current Filter/HME TwinStar® Plus Instructions for Use contain warnings related to condensate. However, we determined that ...

    Waarschuwing | 14-08-2023

  6. St. Jude Medical, FA-Q123-SH-2 Trifecta, Trifecta Valve, Trifecta Valve w. Glide Technology

    Op 27 februari 2023 heeft Abbott al laten weten dat de mogelijkheid van Structural Valve Deterioration (Structurele ...

    Waarschuwing | 14-08-2023

  7. IT2081936-ICU Medical Inc.-MA2306-01-Plum 360 infusion system

    Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not ...

    Waarschuwing | 09-08-2023

  8. Olympus Medical Systems Corporation, Flexible video bronchoscope reusable

    As a result of the complaint investigation, it was determined that the scope (bending section) was too large for the endotracheal ...

    Waarschuwing | 09-08-2023

  9. Thoratec Corporation, FA-Q323-HF-1, HeartMate Touch Communication System

    Een verbinding van HeartMate Touch met een onbedoeld LVAS kan leiden tot veranderingen in LVAS-instellingen die niet bedoeld ...

    Waarschuwing | 07-08-2023

  10. Zimmer Inc., ZFA2023-00156, M.L Taper

    The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa. There has been ...

    Waarschuwing | 07-08-2023