Events

Recall of Elekta MOSAIQ with Evaluate

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Impac Medical Systems Inc.

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
    16720
  • Event Initiated Date
    2014-05-19
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • Reason
    When using 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
    Software to be upgraded

Device

Elekta MOSAIQ with Evaluate
  • Model / Serial
    Model: , Affected: , Software version: Versions 1.40 through 2.50, inclusive
  • Manufacturer
    Impac Medical Systems Inc

Manufacturer

Impac Medical Systems Inc
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    NZMMDSA