Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Covidien (Medtronic) Nellcor™ SpO2 Forehead Sensor 12.16 Nellcor Forehead SpO2 Sensor

   Deze veiligheidsmaatregel (Field Safety Corrective Action, FSCA) wordt uitgevoerd vanwege een fout in de etikettering. Het etiket ...

   Waarschuwing | 06-02-2017

2. Field Safety Notice: Respironics California LLC, V60-beademingsapparaat met softwareversie 2.20

   Een V60-beademingsapparaat waarop softwareversie 2.20 is geïnstalleerd, kan ten onrechte detecteren dat de ventilatormotor is ...

   Waarschuwing | 02-02-2017

3. Siemens Healthcare Diagnostics ISW 17-01 - CentraLink® Data Management System - CentraLink® Data Management System System Software

   Siemens Healthcare Diagnostics has determined that there is a remote possibility CentraLink may download an order to the ADVIA ...

   Waarschuwing | 19-12-2016

4. 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

5. Hamilton Medical Nederland CER39384- HAMILTON-C3

   The analysis of a customer complaint has identified an issue related to SpO2 monitoring with the use of the HAMILTON-C3 ...

   Waarschuwing | 16-08-2016

6. Weinmann FSCA06DRM - OXYWAY

   The inhalation outlet of the above-mentioned pressure reducer is affected. In some cases there has been a deviation between the ...

   Waarschuwing | 18-04-2016

7. Philips R-01-2016-A - Trilogy 100, Trilogy 200, Garbin, Garbin Plus, Trilogy O2, Trilogy 202, Trilogy EC

   De genoemde Trilogy-apparaten ondersteunen de instelling van twee behandelvoorschriften, te programmeren door een ...

   Waarschuwing | 26-01-2016

8. Ambu A.S Ambu2015FA0001 - Ambu® AuraGain™

   A failure has been discovered during routine quality control at the manufacturing site. This failure may cause a small hole ...

   Waarschuwing | 09-12-2015

9. Teleflex 1505‐06 - 551.31 Filtraflux + Softflex

   INMED are recalling the products referenced above as cracking may occur at the 15mm and 22mm ISO female connector. This would ...

   Waarschuwing | 08-12-2015

10. Convatec 2015-03 - Various Nebulizers and Nebulization Kits including Opti-Mist

    ConvaTec/Unomedical is vrijwillig een wereldwijde terugroepactie gestart voor specifieke productcodes en de bijbehorende ...

    Waarschuwing | 19-11-2015