Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Philips Medical Systems Nederland BV, 2023-IGT-BST-024, Philips Azurion 7 M20 FlexArm system with Maquet M

   If, during a procedure, the detector is positioned at a distance of approximately four (4) cm from the patient, the connection ...

   Waarschuwing | 15-12-2023

2. Philips Medical Systems Nederland BV, 2023-IGT-BST-005, Philips Azurion

   Philips has identified a potential issue which can cause the system to continuously restart (restart loop). This is likely to ...

   Waarschuwing | 15-12-2023

3. GME German Medical Engineering GmbH, CAPA 20230928-5, FlexSys

   GME is currently preparing for certification within the new regulatory framework of the Medical Device Regulation (MOR). In case ...

   Waarschuwing | 15-12-2023

4. Welch Allyn, Inc, FA-2023-055, Qstress 6, Xscribe 6

   Baxter Healthcare Corporation is issuing a Correction for the Q‐ Stress and XScribe Cardiac Stress Testing Systems (Q‐Stress ...

   Waarschuwing | 15-12-2023

5. 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

6. Ecolab Deutschland GmbH, ECL-FSCA-001, Incidin OxyWipe S; Incidin OxyFoam S

   Ecolab have retested the product’s efficacy of Incidin OxyWipe S and Incidin OxyFoam S against C. difficile according to the norm ...

   Waarschuwing | 15-12-2023

7. BD, BDB-23-4854, BD® CD11b APC

   BD heeft aan de hand van acht (8) onderzoeken naar klachten van klanten bevestigd dat het bovenstaande lot van BD™ CD11b APC, CE ...

   Waarschuwing | 15-12-2023

8. Cepheid, 23FAR014, Xpert Xpress CoV-2/Flu/RSV plus

   Bepaalde laboratoria die de Xpert® Xpress CoV-2/Flu/RSV plus-test en de beoogde monstertypen gebruiken, hebben een hoger aantal ...

   Waarschuwing | 15-12-2023

9. Olympus Medical Systems Corporation, QIL FY24-EMEA-20-FY24-OMSC-20-GIF-1TH190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

   As a result of testing, Olympus discovered EOG sterilization failures in which the GIF-1TH190 failed to achieve sterilization ...

   Waarschuwing | 15-12-2023

10. Mölnlycke Health Care AB, 2023-11(01), See attached Product Table

    Mölnlycke is onlangs op de hoogte gebracht van een actie die is geïnitieerd door Dispo Medical, de wettelijke fabrikant van het ...

    Waarschuwing | 14-12-2023