Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Thommen Medical AG, 23/01, SPI®ELEMENT impl. RC INICELL®

    Thommen Medical AG is carrying out a recall of a batch of article 4.23.142 "SPI ELEMENT RC INICELL, implant incl. healing cap PF ...

    Waarschuwing | 07-09-2023

  2. Remote Diagnostic Technologies Ltd., 2023-CC-EC-005-IR, Tempus Pro

    An issue has been identified with the Tempus Pro Monitor where an error may occur during video laryngoscope use with the Tempus ...

    Waarschuwing | 04-09-2023

  3. MÉDIPRÉMA, MV2023-01, NITE

    Failure to follow the battery charging procedure, and in particular the recharging times indicated in the user manual, which ...

    Waarschuwing | 01-09-2023

  4. B.Braun Melsungen AG, FSCA-2023-08-21, Original Perfusor® Line

    Tijdens onze post-market surveillance-activiteiten hebben we het risico vastgesteld dat luer-connectoren loskomen van de ...

    Waarschuwing | 31-08-2023

  5. Alba Bioscience Limited (Ltd.), 00003-2023, ALBAcyte® Reagent Red Cells A1

    Investigations have identified that the product is mis-labeled in that one of the three units used to manufacture this reagent ...

    Waarschuwing | 31-08-2023

  6. Scaleo Medical, NCP116, HORIZON P5

    We have been informed that on some instances when running at max setting 5 for 2 hours and at external environment temperature ...

    Waarschuwing | 31-08-2023

  7. Alba Bioscience Limited (Ltd.), 00002-2023, ORTHO™ Sera Anti - Lea

    Een onderzoek naar aanleiding van klachten van klanten heeft bevestigd dat de genoemde partijen ORTHOTM Sera Anti-Lea onverwachte ...

    Waarschuwing | 29-08-2023

  8. PendraCare International B.V., 23-001, Convey Guiding Catheter

    The purpose of this letter is to notify you that PendraCare International B.V. is conducting a voluntary field action/removal for ...

    Waarschuwing | 29-08-2023

  9. Thoratec Corporation, FA-Q323-HF-3, Apical Coring Knife

    Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife could result in an ...

    Waarschuwing | 29-08-2023

  10. Biocomposites Ltd., CC00916, GeneX DS 2.5cc and GeneX DS 5cc

    The Indications should state that ‘genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the ...

    Waarschuwing | 29-08-2023