Events

Recall of Monaco with software versions 3.1 and higher (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-2016-RN-01091-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01091-1
  • 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
    In a specific workflow where contours are edited and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner. if the patient is not saved and recalled, in a subsequently created plan the bev will show the contours as still present while the transverse, sagittal and coronal views will show the contours as deleted. the total volume of the structure reported in the dvh and the structure control will not match. if the study set is saved and reopened before plan creation the total volume of the structure reported in the dvh and the structure control will be corrected. a similar workflow could trigger the defect if contour deletions and edits are performed while a plan is loaded. if the user bases their clinical decisions on incorrect contours it could lead to dose errors and potential patient mistreatment. there have been no reports of injuries due with this issue.
  • Action
    Elekta is advising users to incorporate the one of the following steps into the general contouring workflow: 1. Delete before edit: For newly generated contours, delete any unwanted contours and save before making edits (move, rotate, reshape) 2. If further deletions are required after edits are performed, save and unload the data. Then reload the data before deleting. This will allow the affected code to locate all the coordinate points of the contour. 3. Delete Contour and start over. 4. Clear Contour and start over. Elekta will be implementing a software upgrade as a permanent correction.

Device

Monaco with software versions 3.1 and higher (Radiation therapy treatment planning system)
  • Model / Serial
    Monaco with software versions 3.1 and higher (Radiation therapy treatment planning system)ARTG Number: 215960
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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