Events

Recall of XiO versions 4.50 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-2013-RN-01278-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01278-1
  • 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
    When computing the effective depth (with bolus) to the weight point during treatment planning, xio could use the bolus density for a particular segment of the weight fan when it should be using the ct density. if the ct density is different than the bolus density, the effective depth will be incorrect which will lead to incorrect dose. the problem occurs when the computation of the bolus polygon incorrectly invades the patient contour and overlaps an area where the ct density is much different than bolus density. when the dose is computed along each fanline/depthline, an area of bolus-patient overlap is detected, the incorrect density could be assigned. there is a remote probability of a mistreatment resulting in serious injury.
  • Action
    Elekta is advising users that if all fractions are bolused, a workaround would be to scan the patient with the bolus in place. The incorrect assignment of density to areas of bolus-patient overlap was introduced in XiO Release 4.50.00 and will be resolved in Patch Release 4.80.03 and release 5.00.01. Patch Release 4.80.03 is now available (ie, Jan 2014) and release 5.00.01 is expected to be available by March 2014. This action has been closed-out on 11/02/2016.

Device

XiO versions 4.50 and higher (Radiation therapy treatment planning system)
  • Model / Serial
    XiO versions 4.50 and higher (Radiation therapy treatment planning system)ARTG Number: 99769
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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