Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Philips Goldway Shenzhen Industrial Inc., 2021-CC-EC-023-IR, Efficia External Paddles

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

   Waarschuwing | 29-12-2022

2. Osypka AG, FSCA_002_NCR_155_2022, Cardiac valvuloplasty catheter

   Based on customer feedback, we have determined that a mix-up occurred during the labelling process for these products.

   Waarschuwing | 21-12-2022

3. HeartWare Inc., FA1293, HeartWare™ Ventricular Assist Device (HVAD™) System Hardened Driveline Cover.

   Medtronic maakt u attent op belangrijke veiligheidsinformatie over de kap van de aandrijflijncontroller van het HVAD™- systeem. ...

   Waarschuwing | 14-12-2022

4. Heater Cooler B.V., 2072095, HCTronic

   We would like to inform you about a software bug we found because of feedback we received on 21 November 2022.

   Waarschuwing | 09-12-2022

5. Bard Access Systems Incorporated, PI-22-4510, Catheter Repair Kits

   BD treft momenteel een corrigerende maatregel inzake de veiligheid in het veld om specifieke loten van bepaalde katheter repair ...

   Waarschuwing | 01-12-2022

6. Siemens Healthcare GmbH, FSN-AX057-22-S AX058-22-S FSCA AX059-22-S FSN, Sensis, Sensis Vibe Hemo, Sensis Vibe Combo

   In rare cases (e.g., if an unplanned and unguided shutdown is triggered via the power button) it is possible that during a later ...

   Waarschuwing | 29-11-2022

7. Medtronic, FA944, HVAD® Pump Implant Kits

   Medtronic brengt deze brief uit als vervolg op onze kennisgevingen van december 2020, mei 2021, december 2021 en oktober 2022 met ...

   Waarschuwing | 23-11-2022

8. Becton Dickinson Infusion Therapy AB FSN-MDS-22-4560 BD Connecta Stopcocks

   Becton Dickinson has identified internally that the specific product Lots (listed in Appendix 1) may present a hole or rupture in ...

   Waarschuwing | 08-11-2022

9. HeartWare Inc., FA944, HVAD Pump Implant Kit

   Medtronic is providing this letter as a follow-up to our...communications ... regarding the HeartWare™ Ventricular Assist Device ...

   Waarschuwing | 27-10-2022

10. COMEPA INDUSTRIES, FSN-FSCA-NC017, BBCOM ELECTRODE PEDRIATRIC

    Comepa is immediately recalling from the market the BBCOM Electrodes and PRECOM Electrodes devices. Reason for withdrawal: ...

    Waarschuwing | 24-10-2022