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Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

223 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Lowenstein Medical Technology GmbH Co. KG, FSN-2023-01, LM150TD

    If changes are made to the linking of accessories by changing products or adding accessories, a new circuit test is required to ...

    Waarschuwing | 07-06-2023

  2. Teleflex Malaysia Sdn Bdh Malaysia, EIF-000537, Basic endotracheal tube single-use

    As of 14-April-2023, Teleflex received 173 complaints reporting connector issues for products in scope of this field correction.

    Waarschuwing | 01-06-2023

  3. NOxBOX Ltd, VIG-23-03, NOxBOXi

    NBL has worked with the third-party supplier of the manifold to investigate this issue and has determined that the malfunction is ...

    Waarschuwing | 31-05-2023

  4. Armstrong Medical Ltd, SI22-170, AQUAVENT NEO neonatal CPAP limb heated

    A report has been made to Armstrong Medical of tubing (and a connector attached to the tubing) disconnecting from the elbow ...

    Waarschuwing | 31-05-2023

  5. Philips Respironics, 2023-CC-SRC-003, Trilogy

    Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate ...

    Waarschuwing | 14-04-2023

  6. Covidien llc, FA1323, Shiley Adult FlexibleTracheostomy Tube

    Tijdens ons onderzoek naar deze meldingen van klanten hebben we een fabricagefout ontdekt die ertoe heeft geleid dat de diameter ...

    Waarschuwing | 11-04-2023

  7. Philips Respironics, Inc., 2022-CC-SRC-049, Trilogy Evo O2 Trilogy EV300

    Philips Respironics heeft middels interne tests ontdekt dat de nauwkeurigheid van geleverde zuurstof kan afwijken tot onder de ...

    Waarschuwing | 05-04-2023

  8. 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

  9. Hamilton Medical AG, FSN-CER 101091, HAMILTON-C6

    Safety ventilation can be triggered by switching to an adaptive mode. The display can be restarted by changing the Target Shift ...

    Waarschuwing | 09-03-2023

  10. Remote Diagnostic Technologies, 2022-CC-EC-017, Tempus Pro Patient Monitor

    However, testing revealed that the device does not meet the standards for Fluid and Particulate lngress.

    Waarschuwing | 08-03-2023

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