Events

Recall of XVI R3.5, R4.0, R4.2 and R4.5 (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)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Elekta Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00074-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-01-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00074-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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 (TPS) 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, R4.0, R4.2 and R4.5 (X-ray volume imager intended to confirm patient positioning and su...
  • Model / Serial
    XVI R3.5, R4.0, R4.2 and R4.5 (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
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

Elekta Pty Ltd
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    DHTGA