Events

Recall of Elekta X-ray Volume Imaging System (XVI), software versions 5.0.0 and 5.0.1 (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-2014-RN-01187-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-11-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01187-1
  • 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 rare cases the xvi can incorrectly calculate the target position of the treatment table. the sequence of events when this error occurs is:- the user does an online volumeview acquisition and registration- the user accepts the registration and the table move assistant dialog box appearstwo different scenarios can result:- if the issue occurs only during initial patient set up the absolute actual column of the table move assistant dialog box incorrectly shows blank values. this error can cause a collision between the patient and the external beam limiting device but mistreatment cannot occur as it is not possible to get the table move assistant values in tolerance. - if the issue occurs at times other than initial patient set up the absolute actual column of the table movement dialog can display incorrect values. there is potential for clinical mistreatment if the relative set value is less than 01.Cm.
  • Action
    Elekta is advising all affected users of the mandatory software upgrade which will prevent table movement if the start position has not been recorded correctly. A permanent solution for this problem is now available for all customers running XVI 5.0.0, XVI 5.0.1 systems. An Elekta service team member will contact the customers to install the software upgrade. This action has been closed-out on 07/06/2016.

Device

Elekta X-ray Volume Imaging System (XVI), software versions 5.0.0 and 5.0.1 (Electronic Imaging D...
  • Model / Serial
    Elekta X-ray Volume Imaging System (XVI), software versions 5.0.0 and 5.0.1 (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