Events

Rappel de MobileDiagnost wDR 1 and 2(Mobile digital 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-2015-RN-00524-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-19
  • 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-00524-1
  • 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
    When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behaviour may not be possible. the system can be stopped by releasing the drive handle. proper behaviour is re-enabled when the system is rebooted. the hazard associated to this defect is the potential of a collision.
  • Action
    Philips is preparing a field action kit, which will allow a Philips Service Engineer to replace the existing arrestor strap by a new arrestor with higher resistivity. This will reduce the electromagnetic pulse to a level, which is safe to not disturb the electronics. Users are advised not to try to correct unintended movement using the controls on the drive handle. Instead, stop the system immediately by releasing the drive handle entirely. Alternatively, the emergency button can be pressed. Take special care when the system crosses metal strips or plates on the floor or enters an elevator, as these are situations where electrostatic discharge is likely to occur. This action has been closed-out on 18/08/2016.

Device

MobileDiagnost wDR 1 and 2(Mobile digital x-ray imaging system)

Manufacturer

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