Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Philips Respironics, Inc., 2023-CC-SRC-011, Trilogy Evo and Trilogy Evo O2 ventilators

   During an internal review of the Trilogy Evo and Trilogy Evo O2 Ventilators Instructions for Use (IFUs) manuals, Philips ...

   Waarschuwing | 01-12-2023

2. KARL STORZ SE & Co. KG 22-0002 - Single channel flexible endoscopes with T-Luer

   The correction is limited to a labeling update to correct the Instructions for Use for certain flexible endoscopes and advise ...

   Waarschuwing | 20-04-2022

3. Maquet Critical Care AB, MCC-23-002-IU, Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e

   Internal tests at Getinge have revealed a cybersecurity related vulnerability which potentially could lead to Denial of Service ...

   Waarschuwing | 15-12-2023

4. 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 | 20-11-2023

5. Respironics LLC, 2022-CC-HRC-013, V680 Ventilator

   The purpose of this letter is to communicate a market removal over the next six months of the Philips Respironics V680 (V680) ...

   Waarschuwing | 06-02-2023

6. Maquet Critical Care, MCC/22/007, Servo-air

   During new environmental tests, which includes the possibility that the user steps on the wheelbase, the earlier passed test ...

   Waarschuwing | 06-07-2022

7. Ambu A/S, FSN-Ambu2021FA00001, Ambu SPUR II for demand valve

   The oxygen connector on the Ambu SPUR II for demand valve can in very rare cases deteriorate during storage and present as ...

   Waarschuwing | 20-12-2021

8. Karl Storz SE & Co. KG, FSN-200873725, FIVE S 3.5x65, sterile, for single use

   For products affected, the required sterility assurance level was not achieved during recent testing of the sterilization process ...

   Waarschuwing | 02-09-2021

9. Drägerwerk AG & Co. KGaA, FSN-PR105748, Evita V800,Evita V600,Babylog VN800,Babylog VN600

   Important Safety Notice! Restarts, incorrect alarms about FiO2 concentration, suspension of SmartCare/PS (SC/PS).

   Waarschuwing | 13-04-2021

10. AIR LIQUIDE MEDICAL SYSTEMS FRC 2020-0142 MONNAL EVA UU AND MEMBRANE FOR MONNAL EVA

    Temporary derogation relative to the use of MONNAL EVA expiratory assemblies for the Monnal range ventilators.

    Waarschuwing | 31-03-2020