Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. DH Healthcare GmbH, VR0001031, DeepUnity PACSonWEB

   Door een defect in DeepUnity PACSonWEB kan een gedeeltelijke verwijdering van beelden optreden in een uitzonderlijk scenario.

   Waarschuwing | 10-02-2025

2. Microbiologics, Inc., Recall 2025001, Helix Elite Inactivated QC Sets and Panels

   Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted ...

   Waarschuwing | 10-02-2025

3. IntersurgicaL Ltd., 464552, Anaesthesia breathing circuits, reusable

   We have received some reports of the extendable expiratory gas tubing disconnecting from the system T-piece as shown below, due ...

   Waarschuwing | 07-02-2025

4. Chromsystems Instruments & Chemicals GmbH, FSN 1-2025, MassTox® Antimycotic Drugs/EXTENDED Cali/Con

   We have new data from stability tests that cannot confirm our previous information regarding the storage life of calibrator and ...

   Waarschuwing | 07-02-2025

5. Medtronic, Inc., FA1471, Torqr™ Diagnostic Catheters

   Products associated with the models listed above have incorrect model and lot numbers on the outer box labeling. The inner pouch ...

   Waarschuwing | 07-02-2025

6. Biomet France, ZFA-2024-00248, Optipac® Vacuum mixing system

   Biomet France is conducting a medical device Field Safety Corrective Action (correction) for certain Optipac products due to an ...

   Waarschuwing | 07-02-2025

7. Medtronic, Inc., FA1470, DLP Aortic Root Cannula with Flow-Guard, DLP Aortic Root Cannula with Flow-Guard Introducer, MiAR Aortic Root Cannula with Flow-Guard

   Tijdens het productieproces werd onverwacht los materiaal aangetroffen in de mannelijke luer-aansluiting die in de ...

   Waarschuwing | 07-02-2025

8. Brainlab AG, CAPA-20250117-002791, Multidisciplinary medical image management SW

   Wij schrijven u ter informatie van een mogelijk veiligheidsprobleem bij het gebruik van Brainlab Origin Data Management (ODM) ...

   Waarschuwing | 07-02-2025

9. Rocket Medical PLC, CUST-OCC824/829 (NVFSN-08), Rocket Thoracentesis Catheter 6FG & 8FG

   Rocket Medical PLC has identified a manufacturing issue affecting devices from the lot(s) listed in Table 1. During the ...

   Waarschuwing | 04-02-2025

10. Biomet UK Ltd, ZFA-2024-00261, G7® Acetabular System - Bispherical Cup

    Component loosening is a contributing factor for the reported revision cases. Since August 2020, a total of 28 product complaints ...

    Waarschuwing | 03-02-2025