Events

Recall of Monaco RTP System (Radiation Treatment Planning System Software)

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-00708-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00708-1
  • 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
    This issue affects monaco releases that have been upgraded to 3.20.00 (from 3.10.00) and 3.30.00 (from 3.20.00) and a sample couch parameter file has been edited and saved prior to the upgrade. if the sample couch parameter files are edited (post upgrade), the densities altered, and "save" is selected, the sample files will be updated with these new, user defined densities. if these changes are saved under the original name, when a software upgrade is loaded, the modified couch densities in these sample files will be overwritten with the default value of 1.000.
  • Action
    Elekta is providing work around instructions for users to follow as an interim measure, Elekta is currently working on a preventative action, and will provide further information once this has been determined.

Device

Monaco RTP System (Radiation Treatment Planning System Software)
  • Model / Serial
    Monaco RTP System (Radiation Treatment Planning System Software) Release 3.20.00 and 3.30.00 upgraded from 3.10.00 or 3.20.00 ARTG Number: 186856
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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