Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Respironics California, LLC FSCA 86600042A-IR, FSCA 86600043A-IR, FSCA 86600044A-IR, FSCA 86600045A-IR V60 & V680 Ventilators

   The touchscreen must be used to change certain therapy settings. The touchscreens in affected units may become frozen and fail to ...

   Waarschuwing | 30-08-2019

2. SenTec AG NCR-189 - SDMS (SenTec Digital Monitoring System)

   Due to a manufacturing issue of the electrolyte cartridge of certain Membrane Changer Inserts, there is an increased chance ...

   Waarschuwing | 01-05-2019

3. Field Safety Notice: Newport_Medtronic - Newport™ HT70 (Plus) Ventilators

   The purpose of this letter is to advise you that Medtronic is issuing a Field Safety Corrective Action (FSCA) for all its ...

   Waarschuwing | 05-04-2017

4. Teleflex Medical EIF 000100 - Mucosal Atomization Device (MAD), FlexiNozzle, Laryngo-Tracheal MAD, MADgic, Endotracheal MAD, MADett

   Teleflex Medical recalled these products as they may produce a straight stream instead of a fully atomized plume of medication. ...

   Waarschuwing | 06-03-2017

5. Field Safety Notice: Möller-Wedel - Ceiling Unit CU 5001/3 and CU 3-21/23

   The microscope arm of the mentioned ceiling units can be electrically driven from the parking position into the operating field ...

   Waarschuwing | 28-02-2017

6. Teleflex Medical EIF-000093 - Mucosal Atomization Device (MAD)

   Teleflex Medical has received complaints that the affected lots produced a straight stream instead of an atomized spray. The ...

   Waarschuwing | 02-11-2016

7. Imtmedical ag, FSN-FSCA-2021-002, Diagnostic Package Pulse Oxymetry/Capnography

   It has come to our attention that the CE mark with the Notified Body number (0124) of DEKRA Certification GmbH, was placed in ...

   Waarschuwing | 13-12-2021

8. Field Safety Notice: Medtronic, SynchroMed® II Implanteerbare Infusiepomp

   Update met betrekking tot de communicatie van 2011, voor pompen die gefabriceerd zijn tot en met juni 2011 Fabrikant: Medtronic ...

   Waarschuwing | 14-04-2017

9. Teleflex Malaysia Sdn Bdh, Malaysia, FSN-EIF-000456, TracFlex Plus Tracheostomy Tube Set, CuffedTracFlex Plus PDT Set

   Teleflex has initiated a voluntary Field Safety Corrective Action (FSCA) for the TracFlex Plus Tracheostomy Tube Set, ...

   Waarschuwing | 01-03-2021

10. Philips Medical Systems, FSCA86201863, IntelliVue MX40 Patient Monitor

    Deze brief vervangt de eerdere berichtgevingen met betrekking tot de "Door de klant/gebruiker te ondernemen actie" om risico's ...

    Waarschuwing | 26-04-2019