Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. NIPRO INDIA CORPORATION PVT LTD, FSN-FSCA 20201112, Hemodialyzers

   Urgente veiligheidsmededeling Voorraad vasthouden van specifieke partijnummers van de kunstnieren ELISIO™-H en ELISIO™-M.

   Waarschuwing | 25-11-2020

2. Apollo Endosurgery, Inc. - FSCA-19-001 - BIB/Orbera365 Intragastric Balloon Systems

   Deze corrigerende veiligheidsactie heeft niet betrekking op een malfunctie of defect van een product, maar op een update van de ...

   Waarschuwing | 30-07-2019

3. Field Safety Notice: Cook Medical - Bush DL™and SL™ Ureteral Illuminating Catheter Set

   We have received an increased number of reports where the proximal black component that connects to the distal transparent ...

   Waarschuwing | 20-03-2017

4. Olympus Medical Systems Corporation, QIL FY24-EMEA-13-FY24-OMSC-02-TJF-Q190V-290V-170V, OLYMPUS TJF-Q190V/Q290V/Q170V DUODENOSCOPE

   Olympus is initiating this action after becoming aware of recent reports of infections and positive cultures. Olympus is ...

   Waarschuwing | 28-11-2023

5. Philips Goldway Shenzhen Industrial Inc., 2022-CC-EC-010-IR, Efficia Pads Adapter Cable

   Dit probleem is vastgesteld als gevolg van een klacht van een klant. Philips heeft één melding ontvangen van een overlijden van ...

   Waarschuwing | 10-03-2023

6. Zimmer Switzerland Manufacturing GmbH, ZFA2022-00302, CoCr Femoral Heads

   Zimmer GmbH is conducting a medical device Field Safety Corrective Action (correction) to update the compatibility matrix as ...

   Waarschuwing | 08-03-2023

7. Olympus QIL 154-017 - DUODENOVIDEOSCOPE TJF-Q170V_TJF-Q190V_TJF-Q290V

   End of last year Olympus identified an increase in the number of complaints from customers reporting that mucosal tissue was ...

   Waarschuwing | 23-12-2021

8. Boddingtons, FSN-QIL 154-004 / 2021-001, Endocuff Vision

   This letter refers to the integrity of the sterile packaging of certain Boddingtons Endocuff Vision products which are supplied ...

   Waarschuwing | 10-06-2021

9. Covidien llc, FSN-V45669, Kangaroo Enteral Feeding Non-Sterile Pump Sets

   The purpose of this communication is to inform you that Cardinal Health is issuing a field safety corrective action for all ...

   Waarschuwing | 04-03-2021

10. Olympus Medical Systems Corporation, FSN-QIL 153-010, INTESTINAL VIDEOSCOPE OLYMPUS POWERSPIRAL (PSF-1)

    INFORMATION ON ADVERSE EVENTS OBSERVED DURING POWERSPIRAL (PSF-1) PROCEDURES.

    Waarschuwing | 09-09-2020