Events

Rappel de XVI R3.5.1, R4.2.1 and R4.5.1 (X-ray volume imager intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement during radiation therapy)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Elekta 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-00060-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-01-21
  • 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-00060-1
  • 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
    In some treatment planning systems, the users can contour more than one region of interest with the same structure name. the dicom tags do not contain sufficient information for xvi to identify the different volumes that have the same name. therefore, if the user use dicom rt to send these volumes as one list of contours, it can cause xvi to: - interpolate a contour that identifies the two structures as one structure. - change the contour shape of the volumes in the imported ct reference data and structure sets.
  • Action
    Elekta is advising users to ensure that fields are correct when importing patient data from the treatment planning system and to give different volumes different structure names as a work around. A software release will be provided to correct the issue.

Device

XVI R3.5.1, R4.2.1 and R4.5.1 (X-ray volume imager intended to confirm patient positioning and su...
  • Modèle / numéro de série
    XVI R3.5.1, R4.2.1 and R4.5.1 (X-ray volume imager intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement during radiation therapy)ARTG Number: 165039
  • Classification du dispositif
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Société-mère du fabricant (2017)
    Elekta AB
  • Source
    DHTGA