Events

Recall of MOSAIQ Medical Oncology version 2.50.05 and higher (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-2016-RN-00954-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00954-1
  • 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
    It is possible that a change to an order set will not be saved in the current, open care plan when the following workflow is utilised: 1. open either the care plan edit form or the care plan instance form and leave the form open. 2. select an order set that is part of the same care plan and make a change to the order set. this can be a change to the order set name or label or a change to the drug, dose, administration instructions, etc. 3. the update made to the order set will not be saved in the current, open care plan.Although drug and/or dose information could be edited, but if substantial changes were made to drug information a new order set would be generated rather than editing an existing order set. it is more likely that the edits made would result in non-serious injury (such as administration details, order set name, etc.) there have been no injuries reported as a result of this issue.
  • Action
    Elekta is advising users to ensure all Care Plan windows are closed prior to making and updates to Order Sets. A software correction will be implemented as a permanent correction. This action has been closed-out on 24/05/2017.

Device

MOSAIQ Medical Oncology version 2.50.05 and higher (oncology information system used to manage wo...
  • Model / Serial
    MOSAIQ Medical Oncology version 2.50.05 and higher (oncology information system used to manage workflows for treatment planning and delivery)ARTG Number: 225164
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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