Events

Recall of X-ray Volume Imaging System (XVI), software versions R4.5, R4.5.1, R4.6 and R5.0 (Electronic Imaging Device (EID) used with radiation therapy treatment)

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-01287-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-12-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01287-1
  • 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
    Xvi can incorrectly calculate the target position of the treatment table, because of an error due to a specific sequence of events that does not occur very frequently.If the user does not monitor the patient and treatment table movements, and keeps the table automatic setup (asu) buttons pressed, the treatment table continues to move. it only stops when a touchguard activates. this error can cause a collision between the patient and an external beam limiting device (bld) if: the external bld does not operate with the touchguard attached, or if the external bld extends out more than the touchguard. if the error occurs, fatal injury to the patient could occur. when the error occurs, it is not possible to get the table move assistant values in tolerance. therefore, it is not possible to apply an incorrect correction to the patient position before treatment delivery.
  • Action
    Elekta is providing work around instructions for users to follow. Elekta is advising users to monitor the Actual column of the Table Move Assistant dialog box. If the Actual is blank, do not press the ASU button on the function keypad (FKP). To correct the error, users are advised to restart the XVI, place patient in initial set up position and scan the patient again and continue the usual workflow. A software update will be released for upgrading all XVI R4.5, R4.5.1, R4.6 users to XVI 5.0. A fix to resolve the issue will be developed for XVI R5.0 which is estimated for completion in December 2014.

Device

X-ray Volume Imaging System (XVI), software versions R4.5, R4.5.1, R4.6 and R5.0 (Electronic Imag...
  • Model / Serial
    X-ray Volume Imaging System (XVI), software versions R4.5, R4.5.1, R4.6 and R5.0 (Electronic Imaging Device (EID) used with radiation therapy treatment)ARTG Number: 214673
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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