Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. PAUL HARTMANN AG, FSN-20211007CombiSet, CombiSet® EVAR Tray

   Contamination was found on the Hybrid Drape Protect (size 300x450cm) made of PE and PP film which is included in the CombiSet®. ...

   Waarschuwing | 15-10-2021

2. ViewRay Inc., FSN-3011233554-10-20-2020-001, Stereotacticradiotherapy/MRI System

   ViewRay Inc. has identified two situations where components of the receive coil can reach elevated temperatures which has the ...

   Waarschuwing | 23-10-2020

3. Aesculap AG, FSN-FSCA249, AESCULAP AEOS

   With this letter Aesculap AG would like to inform you about a potential malfunction of product Aesculap Aeos®.

   Waarschuwing | 20-10-2020

4. Bentley InnoMed GmbH CAPA 20-003 Mesh-sleeve coronary artery stent

   During the last internal quality control (destructive testing during final release test), it was found that there is a potential ...

   Waarschuwing | 22-04-2020

5. Galil Medical SM091-2019 - Visual-ICE Cryoablation System

   The desiccant tubes’ robustness and ability to remove moisture from the gas system may have been compromised. This additional ...

   Waarschuwing | 24-01-2020

6. Grace Medical 1010-2019-00001 - Cartilage Microtome System

   Grace Medical, Inc. is issueing a voluntary Field Safety Notice following reported alleged injury to the finger of a user during ...

   Waarschuwing | 21-06-2019

7. Zimmer Biomet ZFA2018-00529 - Oxford Unicompartmental Knee Drill Guides

   Zimmer Biomet is conducting a lot specific medical device field action for the Oxford Unicompartmental Knee Drill Guides (Phase ...

   Waarschuwing | 08-05-2019

8. Zimmer Biomet ZFA2019-00046 - T7 Cannulated Driver AO and T7 Driver Solid AO

   Zimmer Biomet is conducting a removal of the T7 Cannulated Driver AO and T7 Driver Solid AO due to the potential of fracture, ...

   Waarschuwing | 10-04-2019

9. Thommen Medical FSCA 19_01 - Adapter for handpiece, guided reusable

   Thommen Medical AG has found parts in a production batch of the above-mentioned medical device whose hardness does not conform to ...

   Waarschuwing | 27-03-2019

10. US Endoscopy 1528319-02_01_19-R-001 - Padlock Clip defect closure system

    US Endoscopy received a single report of an esophageal laceration during a patient procedure in which our Padlock Clip defect ...

    Waarschuwing | 01-02-2019