Events

Rappel de IntelliSpace Portal with AutoSPECT Pro reconstruction application (image viewing system for diagnostic imaging, x-ray and computed tomography)

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-00364-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-26
  • 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-00364-1
  • 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
    During spect reconstructions using attenuation correction and scatter correction, no scatter correction is being applied in the autospect pro application on intellispace portal with the software versions mentioned above. in addition, resolution recovery is not applied correctly in spect reconstructions using astonish in autospect pro on intellispace portal unless the data is acquired with vxgp collimators. the occurrence of either problem may result in image quality degradation that could result in misdiagnosis under certain conditions.
  • Action
    Philips is providing work around instructions to ensure the continued safe use of the AutoSPECT Pro until a software update can be provided to correct the issue. This action has been closed-out on 12/02/2016.

Device

IntelliSpace Portal with AutoSPECT Pro reconstruction application (image viewing system for diagn...
  • Modèle / numéro de série
    IntelliSpace Portal with AutoSPECT Pro reconstruction application (image viewing system for diagnostic imaging, x-ray and computed tomography)Affected IntelliSpace Portal software versions: v5.0.0, v5.0.1, v5.0.2 and v6.0.0ARTG Number: 188684
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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