Events

Recall of Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) 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-00532-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-06-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00532-1
  • 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
    After the mandatory upgrade of xvi systems from xvi r4.5 to r4.5.1 (tga reference: rc-2012-rn-00456-3), elekta has found that some customers are still operating on the incorrect software build of the xvi r4.5.1 b138 software. the correct build is r4.5.1 b141. the software update from r4.5 to r4.5.1 (tga reference: rc-2012-rn-00456-3) was to permanently correct a software problem that prevents the operation of the database reindex function and also, prevents the error that incorrectly causes a kv gating inhibit during segmental volumeview.
  • Action
    If XVI Release 4.5.1 b141 is displayed on the logon screen, no further action is required. If XVI Release 4.5.1 b138 is displayed end users must contact their service representative immediately. Instructions to complete the upgrade to the correct software build are also being provided to end users.

Device

Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with radiation thera...
  • Model / Serial
    Elekta XVI X-Ray Volume Imager (Electronic Portal Imaging Device (EPID) used with radiation therapy treatment)Software version 4.5.1 b138ARTG number: 165040
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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