Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-32-FY24-OSTA-12, SOLTIVE Single-use Laser Fibers

   Olympus conducted an internal review of the SOLTIVE Single-use Fibers and identified inconsistencies in the IFU. Olympus is ...

   Waarschuwing | 14-12-2023

2. TROKAMED GmbH, 2023 VIG 105233 Morcellator, Griffmodul V2.0 5-times-use Morcellator System

   In rare cases, the Cutting Module may continue to rotate even though the activation switch on the Grip Module has been released.  

   Waarschuwing | 11-07-2023

3. Medtronic FA1259 - TruClear Hysteroscopic Tissue Removal System Control Unit

   Het doel van deze brief is u ervan op de hoogte te stellen dat Medtronic een vrijwillige terugroepactie onderneemt voor de ...

   Waarschuwing | 20-06-2022

4. Olympus Medical Systems Corporation, FSN-QIL 153-015, GASTROINTESTINAL VIDEOSCOPE / COLONOVIDEOSCOPE

   URGENT FIELD SAFETY NOTICE QUARANTINE OF THE EZ1500 SERIES ENDOSCOPES.

   Waarschuwing | 08-01-2021

5. 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

6. 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

7. 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

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. Olympus, QIL 151-010, MAJ-209 SINGLE USE SUCTION VALVE

   Olympus has initiated this action after receiving a complaint of a MAJ-209 breaking during a patient procedure and got stuck in ...

   Waarschuwing | 14-03-2019

10. KARL STORZ SE & Co. KG, FSN-200862159, Video Mediastinoscope

    Urgent bericht inzake de veiligheid in het veld: #200862159 TERUGROEPACTIE 10973HD – videogeassisteerde mediastinoscoop

    Waarschuwing | 14-05-2021