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  1. Beaver Visitec International LTD., FSN-FA-22-008, BVI CustomEyes Packs

    De BVI CustomEyes® verpakkingen van instrumenten, ook bekend als de BVI verpakkingen voor instrumenten voor oogchirurgische ...

    Waarschuwing | 09-03-2023

  2. Helena Biosciences Europe, FSN-NC643, ProtoFluor-Z Reagent Kit

    Mislabeled bottles of the PFZ reagent kit, which prevents calibration of the PFZ instrument. The calibrators of this lot will not ...

    Waarschuwing | 09-03-2023

  3. 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

  4. 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

  5. Philips Medical Systems Nederland, 2022-IGT-BST-012, SmartPerfusion OWB, 2D Perfusion OWB

    Philips has identified through an internal investigation that SmartPerfusion and 2D Perfusion have technical issues related to ...

    Waarschuwing | 08-03-2023

  6. 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

  7. Zimmer Switzerland Manufacturing GmbH, ZFA2022-00302, CoCr Femoral Heads

    Zimmer GmbH is conducting a medical device Field Safety Corrective Action (correction) to update the compatibility matrix as ...

    Waarschuwing | 08-03-2023

  8. EUROS, FSN-FSCA-2023-02, NEMOST - Growing Domino - ø 5.5 mm

    Following one customer complaints, we have noted that the locking ring on the notched rod of the NEMOST device was not tight ...

    Waarschuwing | 07-03-2023

  9. Elekta Instrument AB, FCA-EIAB-0009, Leksell Stereotactic System - Neurosurgical Instru

    Due to a printing error Elekta has shipped out the wrong instructions for use (IFU) when shipping Leksell Stereotactic System ...

    Waarschuwing | 06-03-2023

  10. MicroPort CRM S.r.l., CRM-SAL-2023-001, ENO TEO OTO KORA 250

    Per 23 Februari 2023, heeft MicroPort CRM zes (6) bevestigde klachten ontvangen betreffende een abnormale stijging van de ...

    Waarschuwing | 06-03-2023