Events

Rappel de RayStation software versions 2.5, 3.0, 3.5, and 4.0 (radiation therapy treatment planning 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 Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-00144-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-02-12
  • 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-00144-1
  • 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
    This notice concerns an issue found with the hybrid deformable registration in raystation 2.5, 3.0, 3.5, and 4.0. rigid registration is a standard first step prior to running a hybrid deformation. the rotation component of the rigid registration computed prior to the deformable registration is not accounted for in fusion views when mapping structures (regions or points of interest) or when deforming dose.
  • Action
    Emergo is advising their customers to ensure that the "discard rotation" option is selected in the Image Registration Module before creating a rigid registration intended to be used for hybrid deformable registration. End users can also use the ROI based deformable registration when applicable as this functionality is not affected by the error. A software patch will be release to correct this problem.

Device

RayStation software versions 2.5, 3.0, 3.5, and 4.0 (radiation therapy treatment planning system)

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia