Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Datex-Ohmeda Inc, FSN-FMI 32076, Giraffe Omnibed/Giraffe Incubator

   GE Healthcare has become aware that certain Giraffe Incubators and Giraffe OmniBeds manufactured before 2012 can deliver a ...

   Waarschuwing | 18-05-2020

2. B. Braun Avitum AG, FSN-R-2020-001, xevonta Lo 18, xevonta Hi 18, xevonta Hi 20

   De fabrikant, B.Braun Avitum AG, heeft besloten XEVONTA DIALYZER LO 18 GAMMA terug te roepen van de markt

   Waarschuwing | 07-05-2020

3. Teleflex Malaysia Sdn Bdh, Malaysia, FSN-EIF-000403, Rusch TracFlex Plus Set, cuffed TracFlex Plus PDT Set, Ruschcare TracFlex Plus Set, Cuffed

   Teleflex has voluntarily issued a recall for the products Rusch TracFlex Plus Set, cuffed TracFlex Plus PDT Set, Ruschcare ...

   Waarschuwing | 06-05-2020

4. GAMBRO DASCO, FSN-FA-2020-020, ARTISET HD SN HC, CARTRIDGE SINGLE NEEDLE, ULTRA HDF LINE, ARTISET HD DNL HC and ARTISET PREPOST

   Baxter Healthcare Corporation has received customer complaints of various disconnection events with Artiset blood tubing sets ...

   Waarschuwing | 27-04-2020

5. Organ Assist Products FSCA-CAP-264 - Liver Assist, Kidney Assist and Lung Assist

   Waarschuwingen en foutmeldingen die een te hoge perfusietemperatuur moeten voorkomen, zijn geprogrammeerd in de ingebouwde ...

   Waarschuwing | 16-04-2020

6. Baxter FA-2020-016 - Prismaflex Control Unit, PrisMax

   We have received questions from clinicians who are exploring modifying their use of Baxter's PrisMax and Prismaflex Control ...

   Waarschuwing | 27-03-2020

7. Inpeco S.A. FSCA - AP2 - 202003 - 03 Aptio Automation

   The Centrifuge Module tube loading algorithm included in the firmware versions mentioned above is not in compliance with the ...

   Waarschuwing | 23-03-2020

8. Greiner Bio-One R002_20 - MiniCollect 9NC Coagulation Tube

   As a result of our post market clinical follow up process and based on internal testing, it was identified that MiniCollect® 9NC ...

   Waarschuwing | 04-03-2020

9. Baxter FA-2020-006 - Prismaflex Control Unit

   Baxter is communicating important safety information regarding the use of connectors with the Prismaflex system. The use of ...

   Waarschuwing | 19-02-2020

10. Baxter FA-2020-003 - Revaclear 500

    Baxter Healthcare Corporation is issuing a voluntary product recall for one lot of Revaclear 500 Dialyzers due to reports of ...

    Waarschuwing | 17-02-2020