Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Stryker Joint Replacement, RA2023-3471895, Scorpio, Duracon, PCA, Trident

   The industry guidance for storage duration of Ultra High Molecular Weight Polyethylene (UHMWPE) raw material used in the ...

   Waarschuwing | 19-12-2023

2. Medtronic Navigation Inc., FA1384, Pin, 9733235/9733236, 100MM/150MM, Sterile, Perc Ref

   Medtronic is zich ervan bewust geworden dat bepaalde partijen percutane pennen (zie Tabel 1) een kruispen bevatten waardoor de ...

   Waarschuwing | 19-12-2023

3. New Gene (Hangzhou) Bioengineering Co., Ltd., COVID-19 Antigen Detection Kit - Nasal Swab

   Er is gerapporteerd dat er onvoldoende vloeibare buffer bij het product aanwezig is.

   Waarschuwing | 19-12-2023

4. Siemens Shanghai Medical Equipment Ltd., XP044/23/S, LUMINOS Impulse; Luminos RF Classic; Luminos Select; AXIOM Iconos MD; AXIOM Iconos R100

   This letter is to inform you about a prev entive measure to exclude any potential risk of patient injury caused by t he footrest ...

   Waarschuwing | 19-12-2023

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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