Events

Rappel de DuraDiagnost X-ray System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00089-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-01-30
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00089-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    During recent evaluations of the philips duradiagnost x-ray system, philips have identified a potential issue that may affect the performance of the equipment under certain conditions. 1) if all six t-nuts which are used to mount the x-ray tube arm base to the carriage were not properly assembled, the tube arm assembly could fall. 2) if all eight t-nuts which are used to mount the wall stand detector carrier box and base were not properly assembled, the wall stand detector carrier assembly could fall. 3) if all eight t-nuts which are used to mount the table base and table top floating frame were not properly assembled, the table top could be floating.
  • Action
    A Philips Service Engineer will conduct an inspection to determine if the equipment is affected by this issue. If it is determined that the tube arm and wall stand fixture are not in the correct position the equipment should cease to be used until the tube arm and wall stand fixture have been replaced. A new tube arm and wall stand fixing structure that is designed to prevent this hazard if the tube arm or Wall stand is incorrectly reinstalled in the future will be fitted. This action has been closed-out on 18/07/2016.

Device

DuraDiagnost X-ray System

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA