Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Intersurgical, BVM (Bag-Valve-Mask) Manual Resuscitation Systems

   There is a possibility the valve of the BVM Manual Resuscitation System may become stuck during storage. Fabrikant: Intersurgical ...

   Waarschuwing | 05-06-2017

2. Field Safety Notice: Terumo Corporation, Radifocus® Introducer II,

   De reden voor de terugroepactie is een mogelijke beschadiging van de verpakking die de steriliteit van het product kan ...

   Waarschuwing | 02-06-2017

3. Field Safety Notice: Analyzer versions 1.0.0, 1.1.0 and 1.4.0.0.0.1 of the FluoroType HSV VER 1.0

   In the FluoroCycler Report and in the result window of the Fluoro-Software IVD (tab 'Results HSV") Analyzer versions 1.0.0, 1.1.0 ...

   Waarschuwing | 02-06-2017

4. Field Safety Notice: Beckman Coulter - DxH 500 REF B40601, SW 1.0.2

   As a result of internal investigations, BEC has become aware that when the instrument temperature is exceeded, the DxH 500 allows ...

   Waarschuwing | 02-06-2017

5. Field Safety Notice: Trinity Biotech - Premier Buffer B Reagent

   We are writing to inform you that we have indentified that the closed bottle stability for some bottles of Lot 6524 may be ...

   Waarschuwing | 01-06-2017

6. Field Safety Notice: Medtronic - MiniMed® 640G Insulinepomp

   Middels deze brief willen wij u informeren over een zelden voorkomende, tijdelijke situatie waarbij de knoppen van de MiniMed ® ...

   Waarschuwing | 31-05-2017

7. Field Safety Notice: Siemens - RAPIDLab 348 and RAPIDLab 348EX

   Siemens Healthcare has received a number of reports of gas cartridges failing to install on the RAPIDLab 348 and RAPIDLab 348EX ...

   Waarschuwing | 31-05-2017

8. Field Safety Notice: Bentley InnoMed GmbH, BeGraft Peripheral Plus Stent Graft System

   In het kader van ons markt toezicht proces is opgemerkt dat tijdens het gebruik van de 7 en 8 mm items, volgens de etikettering 7 ...

   Waarschuwing | 31-05-2017

9. Field Safety Notice: Zimmer, Trauma Implants

   Zimmer is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging ...

   Waarschuwing | 31-05-2017

10. Field Safety Notice: Beckman Coulter - Synchron Systems AQUA Cal 1

    Beckman Coulter has confirmed a negative shift of 5 mmol/L for sodium recovery in Synchron Control Level 3 when calibrated with ...

    Waarschuwing | 31-05-2017