Events

Recall of Monaco, Release 3.20.00 - 3.20.01 (Radiation Treatment Planning System)

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-00140-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00140-1
  • 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
    When an arc based plan is created, the beam will have a default "rotation_start" angle. if the start angle for the arc is edited and then the plan delivery type is changed to a non-arc beam, the rotation start angle does not update as it should. the result is that the beam is displayed at the 'gantry' angle, but the dose is calculated at the "rotation_start" angle. if the patient is treated at this beam gantry angle, the patient will not receive the dose that the treatment planning system has calculated and displayed.
  • Action
    The problem was introduced in Monaco Release 3.20.00. The issue is resolved in the Monaco 3.20.02 Patch Release and in Monaco Release 3.30.00. Elekta is asking customers to download software fix from its website.

Device

Monaco, Release 3.20.00 - 3.20.01 (Radiation Treatment Planning System)
  • Model / Serial
    Monaco, Release 3.20.00 - 3.20.01 (Radiation Treatment Planning System)ARTG Number: 186856
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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