Events

Recall of Monaco V 5.11 and V 5.20 (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-01421-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01421-1
  • 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 5.11 or v.5.20 and creating 3d plans and using elekta motorized wedges, that the dose can be incorrectly calculated when using the reset function in monaco. when creating 3d plans using dose weighting mode, if the user rescales the plan, selects “reset”, and then changes the wedge angle, the plan dose and monitor units (mu) should be returned to the original values before the rescale. instead, the system correctly restores the edited wedge field but incorrectly applies the scale reset value again to all other beams in the plan. the clinical impact is that the mus are correct for the non-wedged beams but the dose being presented on the screen is incorrect. therefore the dose displayed will not be what is delivered.
  • Action
    Elekta is advising users that the issue will be resolved with Monaco software releases V 5.11.02 and 5.30, which have estimated release dates of end of January 2017 and end of March 2017, respectively. Elekta is also advising users that, in the interim, 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 V 5.11 and V 5.20 (used for radiation treatment planning)
  • Model / Serial
    Monaco V 5.11 and V 5.20 (used for radiation treatment planning) ARTG Number: 215960
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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