Events

Rappel de MobileDiagnost wDR (Mobile x-ray imaging 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-2014-RN-00565-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-05-20
  • 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-2014-RN-00565-1
  • 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
    The mobilediagnost wdr executes an unintended exposure under the following specific error conditions:- the hand switch is erroneously stuck in pressed position, while the system is switched off, - the system is powered up with the hand switch in that erroneous condition, - the user logs in, selects a patient for examination, gets a green ready light in, - the examination context, if the tube arm is then moved out of the zero position, the system is doing an exposure.The hazard associated to this defect is one single unintended exposure with the parameters configured previously by the user in the last examination. no continuous radiation is emitted in any case.
  • Action
    Philips plans to update the software Philips Service Engineer will contact customers as soon as the Field Action Kit is ready to be implemented. The system can be used according to the Instruction for Use without restrictions. This action has been closed-out on 10/02/2016.

Device

MobileDiagnost wDR (Mobile x-ray imaging system)

Manufacturer

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