Events

Rappel de PET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia Pty 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-2013-RN-01265-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-11-27
  • 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-2013-RN-01265-1
  • 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
    A software issue exists when using list mode replay feature, such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and overcorrection artifacts which may be presented as 'black background' and creates an apparent perfusion defect. reconstructed images with this issue will have many fewer counts than the acquired scan data and a high scatter fraction. this issue may affect studies that use list mode replay and are reconstructed after subsequent acquisitions. this issue may lead to image misinterpretation and/or inaccurate treatment decisions.
  • Action
    GE Healthcare is providing users with work around instructions to follow as an interim measure. A software upgrade will be performed as a permanent fix.

Device

PET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44

Manufacturer

GE Healthcare Australia Pty Ltd