Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: Maquet - Datascope CS100(i)_CS300 Intra­Aortic Balloon Pump (IABP)

   Maquet_Getinge has received a complaint involving a CS300 IABP that did not pump due to an electrical test failure code #58 ...

   Waarschuwing | 19-06-2017

2. Field Safety Notice: Zimmer Biomet, Guide Wires 70cm

   The design verification for the previous packaging configuration does not cover the 70cm wires. While there has not been any ...

   Waarschuwing | 19-06-2017

3. Field Safety Notice: Boston Scientific, Encore™ 26 Inflation Device Single Pack

   De instrumententray van deze partijen kan mogelijk barsten onder bepaalde opslag- en gebruiksomstandigheden, zoals stoten tijdens ...

   Waarschuwing | 19-06-2017

4. Field Safety Notice: Zimmer Biomet, Various Trauma, Extremities, Hips and Knees Implants

   There is a possibility that the patient label inside the product box was incorrectly labeled. The outer box label and the actual ...

   Waarschuwing | 16-06-2017

5. Field Safety Notice: ThermoFisher - B·R·A·H·M·S anti-Tgn RIA

   Starting with B·R·A·H·M·S anti-Tgn RIA lot 119854 we informed you about a shift in the reference range depending on the storage ...

   Waarschuwing | 14-06-2017

6. Field Safety Notice: AngioDynamics, Accu2i pMTA Applicator

   AngioDynamics is recalling product that has the potential to not function during use. Fabrikant: AngioDynamics Product: Accu2i ...

   Waarschuwing | 13-06-2017

7. Field Safety Notice: Drager Medical System, Infinity® Acute Care System

   While using Infinity® Acute Care System Cockpits with 4GB RAM Modules audio or visual alarms may not annunciate on the Cockpit ...

   Waarschuwing | 13-06-2017

8. Field Safety Notice: Nieuwe Weme Technische Montages BV, 4-punts jukken

   Via dit schrijven willen wij u er van op de hoogte stellen dat wij geconstateerd hebben dat de 4-punts jukken met serienummers ...

   Waarschuwing | 13-06-2017

9. Nova Biomedical, Stat Profile Prime

   Nova Biomedical Corporation has recently become aware of a software issue on the Stat Profile Prime Analyzers listed above when ...

   Waarschuwing | 09-06-2017

10. Field Safety Notice: Zimmer Biomet, Comprehensive Nano Humeral Components

    Due to the Comprehensive Nano Humeral Component exceeding the EPR when used in the reverse configuration, Zimmer Biomet is ...

    Waarschuwing | 09-06-2017