Events

Recall of Elekta Integrity R3.0 Digital Linear Accelerator

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-00375-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00375-1
  • 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
    The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values. a fault will occur is the loaded database is incorrect, and could cause clinical mistreatment.
  • Action
    Elekta is advising that the solution to this problem is to upgrade to IntegrityR3.1 as soon as it is available. An updater tool will be available within the next few months and will be Field Safety Modification number 200 02 502 030. This tool is a CD disk that Elekta Service will use on each product to check tolerances and it will adjust if necessary. This is a one-time check unless there is a change to the configuration, such as a new license for the LINAC and then a new check will be needed.

Device

Elekta Integrity R3.0 Digital Linear Accelerator
  • Model / Serial
    Elekta Integrity R3.0 Digital Linear AcceleratorARTG Number: 191025
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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