Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Intervascular SAS, FSN-RC041, HEMAGARD KNITTED Bifurcated grafts

   Following an internal non-conformity report, a textile defect was identified within the body of an Hemagard Knitted bifurcated ...

   Waarschuwing | 13-06-2023

2. Olympus Medical Systems Corporation, QIL FY24-EMEA-03-FY23-OMTA-35-HX-202-LRUR, SINGLE USE REPOSITIONABLE CLIP HX-202LR.UR

   Olympus has become aware of increased complaints on clip deployment occurring during clinical procedures, leading to hazardous ...

   Waarschuwing | 07-06-2023

3. Atrium Medical Corporation, 3011175548-02.15,.2023-001-C, Express Mini 500 Dry Seal Chest Drain

   Atrium/Getinge is initiating a voluntary Medical Device Correction for the Atrium Express Mini 500 Dry Seal Chest Drain. The ...

   Waarschuwing | 28-04-2023

4. GE Medical Systems Israel Ltd., FMI 76194, Vivid i Vivid q Vivid S5 Vivid S6

   GE Healthcare is zich ervan bewust geworden dat als de batterijen in bepaalde oude Vivid-systemen niet na 2 jaar worden ...

   Waarschuwing | 26-01-2023

5. Bolton Medical Inc, 2247858-12-06-2022-001R, RelayPro Thoracic Stent Graft System

   The Efficia External Paddles are intended to be used with the Efficia DFM100 and HeartStart Intrepid Monitor/Defibrillators – by ...

   Waarschuwing | 30-12-2022

6. Volcano Corporation, 2022-IGT-IGTD-001, PV.035 Digital IVUS Catheter

   Philips IGTD heeft een probleem vastgesteld met de gebruiksaanwijzing van de PV.035 digitale IVUS-katheter dat een risico kan ...

   Waarschuwing | 03-06-2022

7. BIOTRONIK, 200000470, Dynetic-35

   During an in-house inspection, Biotronik discovered that a few sterilization pouches of the Passeo-35 Xeo and Dynetic-35 were ...

   Waarschuwing | 03-12-2021

8. Cordis Cashel, FSN-Cordis20211001-EMEA, Cordis S.M.A.R.T. Flex Vascular Stent System

   Cordis has identified that for the lots listed in Table 1 below, there is a potential for distal tip dislodgement / separation ...

   Waarschuwing | 19-10-2021

9. Cordis Corporation Cordis20210720-EMEA - SUPER TORQUE® MB Angiographic Catheter

   Cordis has identified that the SUPER TORQUE® MB Angiographic Catheter (with Marker Bands) are being used in a manner that may ...

   Waarschuwing | 04-08-2021

10. Cordis Corporation, FSN-Cordis20210216-CE, PRECISE PRO RX™ Carotid Stent System

    The purpose of this communication is to inform you that Cordis is recalling (removing) specific lots of Cordis PRECISE PRO RX™ ...

    Waarschuwing | 16-02-2021