Events

Recall of Monaco 5.10.00(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-00910-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-09-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00910-1
  • 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)dose and mu incorrect when ct images viewed from the head: ct images are typically presented as if the viewer is standing at the foot of the couch and looking toward the patient’s head. however, for neurosurgery, images are often created as if being viewed from the top of the couch looking toward the patient’s feet. when ct images are created this latter way and imported in monaco, the image is displayed correctly but the electron densities are incorrectly flipped in both the right-left and superior-inferior directions. the dose distribution and monitor units will be incorrect. 2)dose and mu incorrect when using multiple prescriptions with forced densities:when using multiple prescriptions and the first prescription has forced densities, these forced densities are not being maintained with the second prescription. the dose distribution and monitor units will be incorrect as the initial prescription will use forced densities and the second prescription will use ct densities.
  • Action
    Elekta is advising customers that both problems will be resolved in Monaco Patch Release 5.10.01 which will be available for general release in late September. This action has been closed-out on 19/08/2016.

Device

Monaco 5.10.00(Radiation therapy treatment planning system)

Manufacturer

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