Events

Recall of MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information system software, application program, patient record)

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-2017-RN-00836-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00836-1
  • 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 machine characterization (mac) file is instrumental to the correct operation of mosaiq and your elekta linac. elekta has become aware of the potential for incorrect characterization of couch values, which will lead to incorrect table movements when using couch move assistant (cma). if the mac file is set up incorrectly it is possible that table shifts can be made in the wrong direction.
  • Action
    Elekta is requesting the following: 1. If you are using the Couch Move Assistant (CMA) feature in MOSAIQ , run the verification test(s) given in the Customer Letter to ensure that your table is operating correctly; 2. Users should only run the tests applicable to your clinical workflows on all of your Elekta linacs that are configured for CMA; 3. If the test(s) pass successfully, sign the Acknowledgement form and return the form to Elekta; and 4. If the test(s) fail contact your local Elekta Care Support Centre for assistance.

Device

MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information sys...
  • Model / Serial
    MOSAIQ and Treating on linear accelerators with the RATM license(Elekta Pty Ltd - Information system software, application program, patient record)Elekta Reference Number: FCA-IMS-0024ARTG Number: 225164
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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