Events

Recall of MONACO, version 5.10.00 and above (Radiation therapy 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-2015-RN-01023-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-10-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01023-1
  • 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
    1) in version 5.10.01, the isodose control 100% isodose value (second in the list) was linked to the dose normalisation (dn) value so users would always have a known normalisation value linked to 100% when in relative mode. when the 100% isodose value is edited on the isodose control, the dn is automatically updated. if the user does not notice this update & then rescales to a relative isoline & does not read the dn value displayed on the rescale bar, the rescale could be other than intended. 2) in version 5.10.00 or greater, when the user optimises, then changes the bolus assignment of the beams, and then selects “calculate” (not “optimize” again), the bolus assignment to beams can get scrambled. beams that should have bolus assigned do not and beams that do not have bolus assigned calculate with bolus. the dose distribution and monitor units are incorrect. skin doses could either be higher of lower than intended and this increase or decrease in dose could exceed 5%.
  • Action
    1) The workaround is to only assign one value greater than 100% as the system is defaulted so the 100% isodose line and dose normalisation values are not affected. When rescaling, the dose normalisation value is displayed next to the re-scale value being entered by the user. 2) There is no workaround using the described workflow. However, the problem can be avoided by changing any bolus assignment before optimisation. Both problems will be resolved in Monaco Patch Release 5.10.02. This action has been closed-out on 22/08/2016.

Device

MONACO, version 5.10.00 and above (Radiation therapy treatment planning system)
  • Model / Serial
    MONACO, version 5.10.00 and above (Radiation therapy treatment planning system)ARTG number: 215960
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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