Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Field Safety Notice: OLYMPUS, MONOPOLAR HF RESECTION ELECTRODES

   OLYMPUS has initiated this FSCA after receiving an increased number of complaints regarding loop wires breaking at the distal end ...

   Waarschuwing | 23-05-2017

2. Field Safety Notice: Miele, reinigings- en desinfectieautomaat

   Langs deze weg willen wij u laten weten dat bij een netwerk-penetratietest door een veiligheidsexpert bij het door u gebruikte ...

   Waarschuwing | 07-04-2017

3. Field Safety Notice: WASSENBURG Medical, WASSENBURG® WD440 reinigings- en desinfectiesysteem voor endoscopen

   Deze FSCA moet worden uitgevoerd naar aanleiding van de recent ontdekte fout in de software die in sommige machines het uitvallen ...

   Waarschuwing | 24-02-2017

4. Siemens Healthcare GmbH MR03216S PM00056463 - Combi Dockable Table Neurosurgery

   We have reasons to believe that in some cases the Combi Dockable Table Neurosurgery may have not been properly manufactured. Due ...

   Waarschuwing | 11-10-2016

5. MDSS 16-001, MDD16.152 - NeuroPort Biopotential Signal Processing System

   Blackrock has identified two potential safety risks with the NeuroPort System

   Waarschuwing | 31-08-2016

6. Dräger Nederland B.V PR61967 - Babytherm 8004 & Babytherm 8010

   As part of our market and product monitaring we have become aware of a case in which a Babytherm 8004 without patient was ...

   Waarschuwing | 29-06-2016

7. Merge Healthcare 2016-038 - OrthoCase

   When using the perpendicular line tool, there is an option to “snap” the lines together, which prevents the perpendicular lines ...

   Waarschuwing | 28-06-2016

8. Stryker RA2016-080 - AUTOPLEX SYSTEM

   The valve on the AutoPlex® System’s injection assembly may become blocked, resulting in a cement backflow towards the injector ...

   Waarschuwing | 20-06-2016

9. Limacorporate S.p.A. FSCA no. 02.2015 - SMR glenosphere impactor.extractor

   Monitoring and analysis of the complaints received on the SMR Glenosphere Impactor- Extractor indicate that an improper use of ...

   Waarschuwing | 04-12-2015

10. Siemens MR047,15,S - MAGNETOM systems and Biograph mMR with superconducting magnets

    This letter is to inform you that we have reason to believe that in some cases the quench lines for some superconducting magnets ...

    Waarschuwing | 03-12-2015