Events

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

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-00556-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-05-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00556-1
  • 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
    Patients can be scanned either head first or feet first and these cts imported into monaco for radiation treatment planning. the monaco ct sim workflow gives an option to prepare a feet first plan, but monaco imrt workflow does not. although a patient can be scanned feet first and these feet first cts imported into monaco, the user could incorrectly assume that the intensity-modulated radiation therapy (imrt) plan is feet first as well. when the patient is treated, they could be incorrectly positioned in the feet first position which will not match the plan. if the patient is positioned for treatment in the feet first position, the imrt treatment plan will not match what is delivered, potentially resulting in a significant beam geometry error.
  • Action
    Elekta has updated the Monaco User Guide and on-line help to explicitly indicate that Monaco does not support feet first IMRT planning. The updated information is being provided to end users with the recall correspondence.

Device

Monaco RTP System (Radiation Treatment Planning System Software)All releases of Monaco
  • Model / Serial
    Monaco RTP System (Radiation Treatment Planning System Software)All releases of MonacoARTG Number:186856
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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