Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Olympus Medical Systems Corporation, QIL FY24-EMEA-06-FY24-OMSC-04c, BF-Series Endoscopes

    Olympus has received complaints of endobronchial combustion during therapeutic procedures using lasers or argon plasma ...

    Waarschuwing | 21-07-2023

  2. Karl Storz SE Co. KG, 23-0008, FIVE S 5.3x65 sterile for single use

    Within the revalidation of the sterilization process the revalidation failed.

    Waarschuwing | 12-07-2023

  3. GE Healthcare Finland Oy, FSN-FMI 39004, TruSignal® SpO2 Sensors

    Issue 1: Affected TruSignal SpO2 Sensors (see Table 1 below) can potentially reduce the amount of electrical energy reaching the ...

    Waarschuwing | 06-07-2023

  4. Dragerwerk AG Co. KGaA, PR131287, Carina

    Possible contamination of the breathing gas.

    Waarschuwing | 06-07-2023

  5. Spacelabs Healthcare Inc., FSN-3010157426-03/02/2023-00001-C, Spacelabs Ultraview SL Command Module, Model 91496

    Spacelabs Healthcare is op de hoogte gebracht van verwarring die is ontstaan bij het gebruik van de functie Verwerking ...

    Waarschuwing | 13-06-2023

  6. Intersurgical Ltd, FSN-414091, Superset Fixed Elbow Catheter Mount 22F-22M/15F

    We have received reports of the patient elbow disconnecting from the Superset tube in a number of products.

    Waarschuwing | 13-06-2023

  7. Drägerwerk AG & Co. KGaA, FSN-PR130017, Oxylog 3000 plus

    During the course of our global market surveillance activities, we have become aware of instances where emergency and transport ...

    Waarschuwing | 08-06-2023

  8. 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

  9. 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

  10. 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