Events

Recall of Elekta PreciseTreatment Table (Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use)

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-00255-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-03-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00255-1
  • 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 column rotation can accidentally be moved to a different position while in the locked position. this can occur between fields and can cause clinical mistreatment.
  • Action
    Elekta has provided work around instructions to ensure the treatment table is in the correct position. If end users determine that it is possible to rotate the column with the brakes applied they must contact their service representative. Elekta is currently developing a correction to repair the problem.

Device

Elekta PreciseTreatment Table (Intended as a universal patient treatment support and positioning ...
  • Model / Serial
    Elekta PreciseTreatment Table (Intended as a universal patient treatment support and positioning table for radiation therapy and simulation use)Ranges: 124001 to 126924, 133801 to 133999, 213000 to 213189ARTG Number: 165045
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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