Events

Rappel de Vitrea Enterprise Suite : Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX (Tool for analysis of diagnostic images)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Toshiba 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-00147-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-02-15
  • 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-00147-1
  • 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 internal testing, the manufacturer vital images has found that an error can occur when images are rotated in non-90 degree increments of the transverse/axial plane (rotation around the z-axis), while not being simultaneously rotated around the x-axis and y-axis. this orientation adjustment has been found to occur on rare occasions, such as to straighten tilts in head or neck scans, usually with minimal effect on measurements, but sometimes resulting in differences in length measurements of up to twenty nine percent and in volume measurements of up to fifty percent.
  • Action
    Vital Images recommends that all measurements associated with the issue are verified against results from other technologies. A software patch is under development to correct the issue for software versions 5.2, 6.0,6.1,6.2 and 6.3.

Device

Vitrea Enterprise Suite : Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX (Tool f...
  • Modèle / numéro de série
    Vitrea Enterprise Suite : Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX (Tool for analysis of diagnostic images)All versions prior to 6.3.3, except 6.1.6, 6.2.3 and 6.3 are affectedARTG Number: 154823
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Toshiba Australia Pty Ltd

Manufacturer

Toshiba Australia Pty Ltd