Events

Recall of Monaco V5.10 and V5.20 (used for radiation treatment planning)

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-2016-RN-01281-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01281-1
  • 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
    It has been identified that when running monaco v 5.10 or v 5.20 and creating 3d plans using either mu or dose weighting modes, if the user changes the physician's intent rx dose and the number of fractions, and then modifies the wedge angle, the monitor unit (mu) value is scaled incorrectly. the scaling of the mu is in direct proportion to the fractional change.If the mus are not correct, the patient will be incorrectly treated. there could be a critical overdose or underdose proportional to the fractional rescale. however, prior to treatment, independent dose calculation checks and secondary mu checks should always be done. both should be standards of practice in radiation therapy clinics and will detect the problem.
  • Action
    Elekta is advising users that the issue is resolved with Monaco release 5.11.00 which is available now and with patches for versions 5.10 and 5.20. Elekta is also advising users that dose calculation checks and secondary MU checks should detect the problem, and that the problem can be avoided by forcing a Monaco recalculation (change dose calculation grid spacing and change back) when any wedge angle change is made.

Device

Monaco V5.10 and V5.20 (used for radiation treatment planning)
  • Model / Serial
    Monaco V5.10 and V5.20 (used for radiation treatment planning) ARTG Number: 215960
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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