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Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

223 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Hamilton Medical AG, FSCA 2023-07-03, HAMILTON-C1, HAMILTON-T1, HAMILTON-MR1

    A degrading capacitor on the control board might leak electrolyte onto the control board, causing a short circuit on the board ...

    Waarschuwing | 21-08-2023

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Dragerwerk AG Co. KGaA, PR131287, Carina

    Possible contamination of the breathing gas.

    Waarschuwing | 06-07-2023

  8. 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

  9. 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

  10. 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

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