Events

Recall of All Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric Heads

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-00667-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00667-1
  • 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
    Elekta has advised that some digital accelerators have increased electron applicator auto-tracking settings in the field, to values greater than the factory-set defaults, which can result in an increase of electron applicator radiation leakage in the patient plane, as well as around the applicator.
  • Action
    Elekta are asking users to check all affected machines against the default auto-tracking settings. A software update will be provided as a permanent fix. This action has been clsoed-out on 01/02/2016.

Device

All Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric Heads
  • Model / Serial
    All Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2, Agility or Asymmetric HeadsARTG Number: 111760
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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