Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. QIAGEN GmbH, FSN-CI 3028397, QIAstat-Dx® Respiratory SARS-CoV-2 Panel

   Deze dringende veiligheidsmededeling dient om u erover te informeren dat QIAGEN heeft vastgesteld dat bepaalde partijen van de ...

   Waarschuwing | 08-06-2023

2. B.Braun Melsungen AG, FSCA-2023-05-30, PROSET INTRAFIX SAFESET

   Tijdens kwaliteitsonderzoek is vastgesteld dat een deel van bovengenoemde artikel/charge combinatie mogelijk in verband kan ...

   Waarschuwing | 07-06-2023

3. Olympus Medical Systems Corporation, QIL FY24-EMEA-03-FY23-OMTA-35-HX-202-LRUR, SINGLE USE REPOSITIONABLE CLIP HX-202LR.UR

   Olympus has become aware of increased complaints on clip deployment occurring during clinical procedures, leading to hazardous ...

   Waarschuwing | 07-06-2023

4. Lowenstein Medical Technology GmbH Co. KG, FSN-2023-01, LM150TD

   If changes are made to the linking of accessories by changing products or adding accessories, a new circuit test is required to ...

   Waarschuwing | 07-06-2023

5. Philips Healthcare (Suzhou) Co., Ltd, FSN-2023-PD-CTAMI-102, Incisive CT, CT3500

   Een probleem met de optie Precise Position (Nauwkeurige positie) geïnstalleerd op de Incisive CT‐ en CT 3500‐systemen kan ...

   Waarschuwing | 06-06-2023

6. Optergo AB, CC-NC-0002, Optergo Optical Ergonomic Solutions

   Without regular maintenance and retightening of the screws, as well as with inadequate gluing of the screw, the risk for the ...

   Waarschuwing | 03-06-2023

7. UFSK-International OSYS GmbH, UFSK-FSCA-20230427.sj-d, UFSK-OSYS.Behandlungsstuhl 500 XLE

   Within the scope of our continuous worldwide market observation and the evaluation of information from the field, we have ...

   Waarschuwing | 03-06-2023

8. TAG Medical Products Corporation LTD, 8043971-04.23.23-001-R, BETTA LINK SR KNOTLESS IMPLANT KIT

   The drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due ...

   Waarschuwing | 02-06-2023

9. Philips Medical Systems DMC GmbH, 2023-PD-DXR-008, MobileDiagnost wDR

   Philips has become aware of a software login issue associated with specific models of MobileDiagnost wDR systems running on ...

   Waarschuwing | 01-06-2023

10. Teleflex Malaysia Sdn Bdh Malaysia, EIF-000537, Basic endotracheal tube single-use

    As of 14-April-2023, Teleflex received 173 complaints reporting connector issues for products in scope of this field correction.

    Waarschuwing | 01-06-2023