Events

Recall of Digital Linear Accelerators fitted with X-ray Volume Imaging (XVI)Machine Range: 105345 to 151675 (inclusive)

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-2012-RN-00822-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00822-3
  • 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 digital linear accelerator gantry base wheel bolts have been found to become loose and fail in some instances.
  • Action
    Elekta is informing customers that all gantry base wheel bolts should be checked and they should be replaced if found to be showing signs of fatigue.

Device

Digital Linear Accelerators fitted with X-ray Volume Imaging (XVI)Machine Range: 105345 to 151675...
  • Model / Serial
    Digital Linear Accelerators fitted with X-ray Volume Imaging (XVI)Machine Range: 105345 to 151675 (inclusive),ARTG Number: 111760
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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