Events

Recall of Precise Treatment Table ( A 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-2014-RN-00927-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-08-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00927-1
  • 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 have identified that it is possible to get a positional error with the precise treatment table. this can occur if the positional sensors are not correctly installed during corrective maintenance. the system has a software check for large positional errors which is intended to find faults, but it is possible to position the treatment table with errors greater than 5mm and no inhibits are displayed. it is possible to cause a clinical mistreatment if the patient is not in the correct position.
  • Action
    Elekta recommends the customers to verify the accuracy of the treatment table position using the procedure as shown by the treatment room monitor (TRM) as part of the daily machine checks. Elekta will supply an improved method of check/test for service engineers to implement post maintenance on the potentiometers to ensure they have correctly installed the positional sensors. This action has been closed-out on 12/08/2016.

Device

Precise Treatment Table ( A patient treatment support and positioning table for radiation therapy...
  • Model / Serial
    Precise Treatment Table ( A patient treatment support and positioning table for radiation therapy and simulation use.) Serial Numbers: 124001-125803, 125807-880, 125883-899, 125902-917, 125920-949, 125952-963, 125967-125153, 126158-170, 126174-208, 126212-230, 126232-261, 126269-281, 126293-309,126318-330, 126338-126373, 126375-397, 126400-133999 & 213000+ARTG Number: 165045
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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