Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. GAMBRO DASCO, FSN-FA-2020-068, Haemodialysis tubing set single-use

   Baxter Healthcare Corporation has received customer reports of kinked access lines observed during treatment using cartridge sets ...

   Waarschuwing | 06-01-2021

2. FUJIFILM Corporation, FSN-ECN-G1717, FUJIFILM 580-U Series and 700 Series

   FUJIFILM geeft dit Veiligheidsbulletin uit voor de endoscopen van het type EG-760R, EG-760Z, EC-760R-V/M, EC-760R-V/I, ...

   Waarschuwing | 24-09-2020

3. Olympus Medical Systems Corporation, FSN-QIL 153-009, OES CHOLEDOCHOFIBERSCOPE OLYMPUS CHF TYPE CB30S

   Olympus Medical Systems Corporation (“Olympus”) is writing to inform you of a removal action of all OES CHOLEDOCHOFIBERSCOPE ...

   Waarschuwing | 09-09-2020

4. GAMBRO DASCO, FSN-FA-2020-020, ARTISET HD SN HC, CARTRIDGE SINGLE NEEDLE, ULTRA HDF LINE, ARTISET HD DNL HC and ARTISET PREPOST

   Baxter Healthcare Corporation has received customer complaints of various disconnection events with Artiset blood tubing sets ...

   Waarschuwing | 27-04-2020

5. Olympus Medical Systems Corporation QIL 152-006 OLYMPUS DUODENOVIDEOSCOPES & DUODENOFIBERSCOPES

   Olympus has received complaints about fraying elevator wires of Olympus Duodenovideoscope JF-260V ,TJF-260V and TJF-160VR. ...

   Waarschuwing | 15-11-2019

6. Gambro Lundia, FA-2019-050, Prismaflex Control Unit

   Baxter Healthcare will be upgrading the software on Prismaflex control units to reduce the frequency of communication error ...

   Waarschuwing | 11-10-2019

7. Gambro Lundia, FA-2019-023, Prismaflex System

   Er is vastgesteld dat de calcium-spuitpomp inactief kan worden zonder dat het alarm afgaat wanneer de spuit vervangen is.

   Waarschuwing | 23-05-2019

8. Olympus Medical Systems Corporation, QIL 152-001, OLYMPUS Duodenovideoscope

   Olympus has received complaints about fraying elevator wires of the TJF-160VR, but these complaints have not resulted in any ...

   Waarschuwing | 07-05-2019

9. Baxter Healthcare FA-2019-019 - Prismaflex sets

   Baxter Healthcare Corporation has received customer reports of kinked access lines observed during treatment using Prismaflex ...

   Waarschuwing | 25-04-2019

10. Olea Medical VIG-OM 19_01- Olea Sphere V3.0

    Given the relative novelty of SMS/multi-band type of acquisition and the lack of consensus in the current state of the art about ...

    Waarschuwing | 18-04-2019