Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Boston Scientific Corporation, FSN-92583333-FA, Hurricane RX Biliary Balloon Dilatation Catheter

   Boston Scientific Corporation (BSC) start de terugroepactie van specifieke lots/batches van Hurricane™ RX biliaire ...

   Waarschuwing | 16-09-2020

2. Applied Medical 2027111-03_11_20-002-R - Epix latis Grasper

   Applied Medical voert een vrijwillige terugroepactie uit van specifieke lotnummers van de Epix latis Paktangen, wegens de ...

   Waarschuwing | 25-03-2020

3. Unimax Medical Systems, Inc., FCA-EP24001, Detachable EndoRetrieval Pouch

   The mechanism of the listed article number operates in a way that the tube within detaches during the removal process. If the ...

   Waarschuwing | 18-03-2024

4. Intuitive Surgical ISIFA2022-02-C - SureForm 45, SureForm 45 Curved-Tip, SureForm 60

   Deze veiligheidsmelding is bedoeld om u op de hoogte te brengen van de kans op verwondingen in verband met de SureForm-niettangen ...

   Waarschuwing | 20-04-2022

5. Intuitive Surgical ISIFA2021-08-R - da Vinci Xi and X 12-8 mm Cannula Reducer

   Het doel van deze brief is om u te informeren dat Intuitive op de hoogte is gebracht dat de kans bestaat dat de metalen tip op ...

   Waarschuwing | 12-01-2022

6. Getinge Disinfection AB, FSN-CAPA 657266, Getinge ED-FLOW Range

   Getinge has discovered that washer disinfector ED-FLOW AER range potentially exhibit behavior due to a system error whereby, ...

   Waarschuwing | 03-11-2022

7. Olympus Medical Systems Corporation, QIL FY24-EMEA-38-FY24-OMSC-06, High Flow Insufflation Unit

   Olympus has become aware of an increased trend from both repairs and customer complaints of the “UHI-4 stopping CO2 gas supply ...

   Waarschuwing | 03-04-2024

8. Boston Scientific Corporation, FSN-92926415-FA, ORISE™ Gel Submucosal Lifting Agent

   Boston Scientific heeft onlangs ontdekt dat er bijwerkingen optraden die werden gekoppeld aan een reactie op vreemde voorwerpen ...

   Waarschuwing | 24-10-2022

9. Olympus, QIL FY24-EMEA-19-FY24-OMSC-19, High Flow Insufflation Unit

   Olympus has become aware of patients experiencing complications from over insufflation, including arrythmias reported as “short ...

   Waarschuwing | 01-12-2023

10. Richard Wolf GmbH, FSN-FSCA700020652, FLEX. GRASP. FORCEPS or FLEX. BIOPSY FORCEPS

    We have received complaints from users stating that the forceps can no longer be opened during use. Our investigation has shown ...

    Waarschuwing | 23-03-2023