Events

Rappel de Brilliance CT and Ingenuity CT with software versions v4.13 and v4.1.4 (Computed tomography full-body 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-2016-RN-00340-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2016-03-23
  • 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-2016-RN-00340-1
  • 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
    On the affected ct systems and software versions, the issue relates to the auto transfer to the remote devices (such as pacs), where there is a possibility for intermittent failures to send all images/data series automatically. the images remain on the local storage device until manually transferred to the remote device.
  • Action
    Philips is advising users of affected CT systems to assure that all images are transferred by checking that images are available on any remote devices before images/data series are deleted from local storage device. If there are missing images/data series on remote devices, the user can manually transfer images/data series to remote devices. Philips will be completing a software upgrade as a permanent fix. This action has been closed-out on 23/06/2017.

Device

Brilliance CT and Ingenuity CT with software versions v4.13 and v4.1.4 (Computed tomography full-...
  • Modèle / numéro de série
    Brilliance CT and Ingenuity CT with software versions v4.13 and v4.1.4 (Computed tomography full-body x-ray system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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