Events

Rappel de PET VCAR Application Software (installed on Advantage Workstation and AW Server versions: Advantage Workstation 4.6, Volume Share 5 enhanced - vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced - vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 )

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-00526-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-05-24
  • 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-00526-1
  • 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
    When using a customised pet vcar percist protocol with more than 1 target lesion selected for response calculation, the software may compute an incorrect response percentage and/or criteria whereby the number of lesions used to calculate response on the prior study is different than the number of lesions used to calculate response on the follow-up study. in which case, the response criteria generated under this condition will compare the sum of the target findings from the prior to the sum of findings on the follow-up study resulting in an incorrect response percentage. this error could lead to an incorrect response criteria categorisation [i.E. a patient that is responding to treatment (partial metabolic response - pmr) could be categorised as not responding (stable metabolic disease - smd) or progressive (progressive metabolic disease - pmd).] miscategorisation of this type could lead to changes in the course of patient treatment.
  • Action
    Customers are advised that when using PERCIST for treatment and therapy assessment, they should use the “Highest only” Target Lesions selection within the custom preset or use the default PERCIST_1.0 preset provided with the software. If site specific custom protocols are being used, customers are advised to implement temporary work around instructions. GE Healthcare will correct all affected systems once a software update is available which is expected to be released in July 2013.

Device

PET VCAR Application Software (installed on Advantage Workstation and AW Server versions: Advanta...
  • Modèle / numéro de série
    PET VCAR Application Software (installed on Advantage Workstation and AW Server versions: Advantage Workstation 4.6, Volume Share 5 enhanced - vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume Share 5 enhanced - vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 )ARTG number: 153390
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd