Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Olympus Medical Systems Corporation, QIL FY24-EMEA-01-FY23-OMTA-13 for MAJ-2315 Single, Single use Distal cover MAJ-2315

   Olympus has become aware that the Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the ...

   Waarschuwing | 20-04-2023

2. Karl Storz SE & Co. KG, FSN-200873725, FIVE S 3.5x65, sterile, for single use

   For products affected, the required sterility assurance level was not achieved during recent testing of the sterilization process ...

   Waarschuwing | 02-09-2021

3. KARL STORZ SE & Co. KG, FSN-20082557, KARL STORZ OR1 FUSION CONTROL

   Actualisering apparaatsoftware en aanbevolen dringende maatregelen betreffende WO300 OR1 FUSION CONTROL® .

   Waarschuwing | 29-09-2020

4. Verathon Medical FCAA-0004 - GLIDESCOPE® GVL 2 STAT

   Verathon Inc. has become aware that product labelled as GVL® size 2 Stat lot GC32825 was physically packaged with GVL® size 1 ...

   Waarschuwing | 01-03-2017

5. Intuitive Surgical ISIFA2022-01-C - da Vinci X/XI Vessel Sealer Extend and SynchroSeal Instruments

   Deze veiligheidsmededeling is bedoeld om u erop te wijzen dat Intuitive zich ervan bewust is geworden dat het plaatsen van ...

   Waarschuwing | 15-03-2022

6. Intuitive Surgical, Inc., ISIFA2023-02-R, Tip-Up Fenestrated Grasper

   Dit fabricageprobleem kan mogelijk resulteren in het (af)breken van het bovenste en/of onderste bekje.

   Waarschuwing | 16-06-2023

7. Maquet Cardiovascular, LLC/Getinge, 2242352-05/21/2024-001-C, VASOVIEW HEMOPRO, VASOVIEW HEMOPRO 2

   lf there is fluid ingress into the handle of the operating tool, the device may not provide cautery or may continue to provide ...

   Waarschuwing | 20-06-2024

8. Olympus Medical Systems Corporation, FSN-QIL FY24-EMEA-10-FY24-OMSC-05, PowerSpiral Intestinal Videoscope PSF-1

   Recall - Market removal of PowerSpiral PSF-1 and associated accessories DPST-1 and PSCU Olympus had become aware of a situation ...

   Waarschuwing | 11-07-2023

9. Olympus Medical Systems Corporation, FSN-QIL 153-016, Olympus TJF-Q170V &TJF-Q190V & TJF-Q290 & MAJ-2315

   The safety notice pertains to the referenced Olympus endoscope models and the disposable distal cover: DUODENOVIDEOSCOPE ...

   Waarschuwing | 11-02-2021

10. Olympus QIL 153-016 - DUODENOVIDEOSCOPE TJF-Q170_TJF-Q190V_TJF-Q290V and DISTAL COVER MAJ-2315

    Olympus has identified an increase in the number of complaints from customers reporting that mucosal tissue was found within the ...

    Waarschuwing | 11-02-2021