Events

Recall of MOSAIQ Versions 1.40 through 2.50, inclusive (Oncology information system used to manage workflows for treatment planning and delivery)

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-2014-RN-00560-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00560-1
  • 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
    When using mosaiq couch move assistant (cma), if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse pointer to a different area of the screen. likewise, if the user hovers the mouse pointer exactly above the site dropdown and uses the mouse thumbwheel or touchpad scroll bar, the site could change and the direction and offset will change depending on the site selected. an inadvertent change can also occur if either the direction or site dropdown is selected, the mouse pointer is anywhere on the dialog, and the mouse thumbwheel or touchpad scroll bar is used.
  • Action
    Users are advised that the problem can be avoided by moving the mouse pointer away from the Direction or Site dropdowns or by making sure these options are not selected when using the thumbwheel or touchpad scroll bar. This problem will be resolved in a future MOSAIQ software release. This action has been closed-out on 11/04/2016.

Device

MOSAIQ Versions 1.40 through 2.50, inclusive (Oncology information system used to manage workflow...
  • Model / Serial
    MOSAIQ Versions 1.40 through 2.50, inclusive (Oncology information system used to manage workflows for treatment planning and delivery)ARTG Number: 206321
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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