Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. ConMed Corporation, MDSS ref.: MDD19.090, Anchor Tissue Retrieval System™

   CONMED has received complaints that the individual device pouch had a void in its seal.

   Waarschuwing | 20-03-2019

2. CHIRANA T.Injecta, a.s., FSN-2020-CH-09, Sterile hypodermic / blunt fill needle - MEDOJECT

   The observation that the needle surface gives black color when touched by white tissue may potentially rise some concerns about ...

   Waarschuwing | 29-09-2020

3. Teleflex Malaysia Sdn Bdh, Malaysia, FSN-EIF-000403, Rusch TracFlex Plus Set, cuffed TracFlex Plus PDT Set, Ruschcare TracFlex Plus Set, Cuffed

   Teleflex has voluntarily issued a recall for the products Rusch TracFlex Plus Set, cuffed TracFlex Plus PDT Set, Ruschcare ...

   Waarschuwing | 06-05-2020

4. Medline International FSCA-22/07 - MED-SOFT liners

   Medline is begonnen met een inspectie van L-verbindingsstukken ter vervanging van defecte verbindingsstukken die gebruikt zijn ...

   Waarschuwing | 27-06-2022

5. Maquet Cardiopulmonary GmbH, 879551, CARDIOHELP-i

   The IFU of the CARDIOHELP system states incorrect factory settings. The device itself is working as intended and the error only ...

   Waarschuwing | 10-11-2023

6. Terumo FSCA1902 05-19 - Electronic Patient Gas System (EPGS) Flowmeter APS-1

   Terumo Cardiovascular Systems (Terumo CVS) start een vrijwillige correctie in het veld van de interne flowmeter van het ...

   Waarschuwing | 16-05-2019

7. Delcath Systems Inc, FSN-HHE 2021-001, CHEMOSAT

   Delcath Systems is providing this Field Safety Notice after reports were received of the silicone valve in the 18F Sheath ...

   Waarschuwing | 09-03-2021

8. Maquet Cardiopulmonary GmbH, FSN-FSCA-2020-07-31, Heater Unit HU 35, ROTAFLOW System and ROTAFLOW System with ROTAFLOW ICU Console

   Due to the update of the IEC Standard 60601-1-2 for Electromagnetic compatibility (EMC) to its 4th edition, the medical devices ...

   Waarschuwing | 05-08-2020

9. Maquet Cardiopulmonary GmbH, 881841, Cardiohelp-i

   The root cause of the improper contact originates in an incorrect drawing of the production tool in question, resulting in an ...

   Waarschuwing | 06-11-2023

10. Maquet Cardiopulmonary GmbH, 881842, Cardiohelp-i

    A noticeable high number of breaks in the insulation sheath and a shielding breach of the venous probe connection cable was ...

    Waarschuwing | 20-11-2023