Events

Recall of Elekta Integrity Digital Linear Accelerator, version 1.1

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-00334-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00334-1
  • 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
    If the "static tolerances" in the calibration files (loaded database) for the unwanted movement during the beam delivery are incorrect, the unwanted movement may not terminate treatment. this is only a problem if a malfunction such as a brake failure or an equivalent fault occurs during beam delivery.
  • Action
    Elekta is advising that the solution to the problem is to apply the Integrity 1.1 Static Tolerance Updater Tool. This tool will need to be re-applied, if a new Linac license is applied in the future. A complete solution will be included in the next release of the software.

Device

Elekta Integrity Digital Linear Accelerator, version 1.1
  • Model / Serial
    Elekta Integrity Digital Linear Accelerator, version 1.1ARTG Number: 191025
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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