Events

Recall of MOSAIQ versions 2.41 and higher (Oncology information system used to manage workflows for treatment planning and delivery)Sites affected will be those meeting ALL three criteria below:1) Running MOSAIQ Release 2.41 and higher 2) With at least one linac equipped with an Agility 160 multi-leaf collimator (MLC) head (Versa HD, Infinity, Axesse (EOS) or Synergy) 3) Who are treating with Stereotactic Cones

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-00608-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-07-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00608-1
  • 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
    A problem exists in mosaiq resulting in the incorrect field size being sent to the treatment machine for stereotactic plans. when a stereotactic field is imported or promoted, and the treatment field definition is opened:- the mlc shape will be correct for the planned cone field size, and- the user will also see the field size displayed with x=40 and y=the jaw setting for the planned cone. if simple mlc is selected, without changing the jaw size, the mlc shape will move the virtual x jaw to its most retracted position of 40. when the user clicks “ok” to accept the field change, they are presented with the field delta window and they must click “accept” for the change to take effect. if the mlcs are not edited to return to the correct shape for the planned cone, the user can unintentionally save the virtual jaw settings as the mlc shape resulting in a treatment field much larger than intended. the problem occurs because simple mlc is resetting the mlc positions.
  • Action
    The problem can be avoided by clicking Cancel on the Create Simple MLC window, editing the field size values in the Create Simple MLC window to return to the correct MLC shape for the planned cone before saving or by not using the Simple MLC view. This problem will be resolved in a future release of the current MOSAIQ versions 2.41, 2.50, 2.60, 2.62. Elekta will inform the affected customers when the relevant MOSAIQ build is released containing the fix. This action has been closed-out on 8/08/2016,

Device

MOSAIQ versions 2.41 and higher (Oncology information system used to manage workflows for treatme...
  • Model / Serial
    MOSAIQ versions 2.41 and higher (Oncology information system used to manage workflows for treatment planning and delivery)Sites affected will be those meeting ALL three criteria below:1) Running MOSAIQ Release 2.41 and higher2) With at least one linac equipped with an Agility 160 multi-leaf collimator (MLC) head (Versa HD, Infinity, Axesse (EOS) or Synergy)3) Who are treating with Stereotactic Cones ARTG: 206321
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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