Events

Recall of XiO Software build versions 4.1 and higher (Radiation therapy treatment planning system)

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-00275-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00275-1
  • 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
    Dose and monitor unit values are not computed correctly when elekta motorised wedges are used with dynamic conformal arcs. the problem occurs because only the start and stop angles of the dynamic conformal arcs are computed when all sub-beams of the arc should be computed. the planned dose distribution will not reflect the delivered dose. some anatomical structures will receive more dose than the plan reflects, some will receive less dose. it is possible that the target could likewise receive more or less dose than what is reflected in the plan. there is a remote probability of a mistreatment resulting in serious injury.
  • Action
    Users are advised that the problem can be avoided by not using Elekta Motorised Wedges with Dynamic Conformal arcs. The problem was introduced in XiO Release 4.1 and will be resolved in Release 5.00.01 which will be released by March/April 2014.

Device

XiO Software build versions 4.1 and higher (Radiation therapy treatment planning system)
  • Model / Serial
    XiO Software build versions 4.1 and higher (Radiation therapy treatment planning system)ARTG Number: 99769
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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