Events

Rappel de DigitalDiagnost, Release 4.1/4.1.1 (Digital diagnostic 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-00736-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-13
  • 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-00736-1
  • 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 system is designed to emit an acoustic signal (beep) upon termination of an exposure. however, if the system has been powered on for more than 12 hours, the system will no longer emit this signal. if this occurs, the system operator may be unsure that the exposure was correctly obtained, which may result in the decision to repeat an exposure.
  • Action
    Philips plans to install a software upgrade (i.e., Release 4.1.2) in affected systems, which will eliminate this issue. A Philips Service Engineer will contact affected customers when the Field Action Kit is available to be implemented. Until the system software is upgraded to release 4.1.2 to eliminate the potential loss of the acoustic signal upon termination of an exposure, Philips recommends that the system is rebooted at least every 11 hours. This action has been closed-out on 22/08/2016.

Device

DigitalDiagnost, Release 4.1/4.1.1 (Digital diagnostic X-Ray system)

Manufacturer

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