Events

Rappel de DigitalDiagnost (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-2012-RN-01224-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-12-07
  • 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-2012-RN-01224-1
  • 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
    Philips previously notified owners of digitaldiagnost systems with software releases 3.0.1 and 3.0.2, that a new software release 3.0.3 would be installed on their systems (without due consultation with the tga). however, software release 3.0.3 contained a defect that may result in the incorrect placement of the electronic marker (left/right) indicating the patient side of an image is rotated. software release 3.0.4 corrects this defect in release 3.0.3, and it will be installed on affected systems in place of release 3.0.3.When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. when the operator manually rotates the image back, electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
  • Action
    Update to system software

Device

DigitalDiagnost (Digital diagnostic X-Ray System).
  • Modèle / numéro de série
    DigitalDiagnost (Digital diagnostic X-Ray System). All systems with Eleva software version 3.0.xARTG Number: 117662
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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