Events

Recall of MOSAIQ Medical Oncology with software version 2.50.05 and higher

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-2017-RN-00803-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00803-1
  • 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
    Elekta has identified an issue where in the care plan library, double clicking to add or delete a component/procedure to an order set does not trigger the update of the associated care plans. the care plans in the care plan library remain pointing to an obsolete version of the order set.
  • Action
    If the Component/Procedure is edited by selecting it (instead of double clicking), the problem does not occur and the Care Plan updates as expected. A permanent fix will be made in future software release 2.65 Beta 01.

Device

MOSAIQ Medical Oncology with software version 2.50.05 and higher
  • Model / Serial
    MOSAIQ Medical Oncology with software version 2.50.05 and higherARTG Number: 225164
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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