Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Zimmer ZFA2017-266 - Pulsavac

   Zimmer Biomet wishes to emphasize and reiterate the battery disposal recommendations both within the instruction for use (IFU) of ...

   Waarschuwing | 23-10-2017

2. Beckman Coulter FA-000402 - DxA 5000

   De gebruiksinstructies voor de DxA 5000 zijn mogelijk verwarrend omtrent het hergebruik van monster-ID's. Beckman Coulter heeft ...

   Waarschuwing | 23-06-2020

3. ECM Europe B.V., ECM-2022-CAPA-13, Liver Assist Dual-Set

   Er is een kwaliteitsdefect vastgesteld voor de Liver Assist Dual Set, zoals beschreven in deze veiligheidsmededeling.   

   Waarschuwing | 26-01-2023

4. OrganOx Ltd, FSN-2021-003, Metra Retained Unit

   OrganOx Ltd is issuing a Field Safety Corrective Action (FSCA) for the OrganOx metra Retained Unit (P/N D0003). This FSCA affects ...

   Waarschuwing | 04-06-2021

5. Olympus Corporation of Americas, QIL FY23-EMEA-13, Single use aspiration needle

   Olympus became aware of a manufacturing non-conformance pertaining to the angle of the needle in that it did not meet ...

   Waarschuwing | 13-04-2023

6. Argon Medical Devices FSCA 2020-12-10-1 - TLAB Transjugular Liver Biopsy System

   Argon Medical received complaints from our customers regarding the TLAB Transjugular Liver Biopsy System for a potential defect ...

   Waarschuwing | 10-12-2020

7. LifeCell Corporation, Revolve Advanced Adipose System

   The Revolve System is labelled as “Non-Pyrogenic”, however there were no prior release criteria for finished product endotoxin ...

   Waarschuwing | 19-09-2017

8. HEMODIA, FSN-MV22-022, Patient set for Aqua-vision

   As part of the post-market surveillance, HEMODIA, legal manufacturer, has been informed by its customers of an incident involving ...

   Waarschuwing | 08-11-2022

9. Cerus Corporation, FSN-QE-000211, INTERCEPT Processing Set for Plasma

   Field Safety Notice INTERCEPT Blood System for Plasma, Processing Set for Plasma: Mislabelling in the Instructions for Use and ...

   Waarschuwing | 28-05-2021

10. Integra LifeSciences (Ireland) Limited, 2024-HHE-006, Cusa Excel 23kHz Straight Handpiece

    The decision to conduct a voluntary correction of the product was based on the following: through an internal investigation of ...

    Waarschuwing | 03-06-2024