Events

Recall of MOSAIQ 2.62 and higher with the IQ Scripts license enabled (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-00781-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00781-1
  • 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
    Clicking on the treat button in the treatment chart window will trigger the plan-of-the-day iq script to run. the plan-of-the-day window will open and the treatment plan can be selected by clicking on the radio button. it is possible that the selected plan-of-the-day could be accidentally changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.Though the wrong plan-of-the-day selected for one fraction would likely not result in critical harm, if the wrong plan were selected multiple times it could result in serious injury.
  • Action
    The issue is corrected in the general release of MOSAIQ 2.64. A software patch will be released for MOSAIQ version 2.62 in order to correct the defect. In the interim, the problem can be avoided by careful use of a mouse with a wheel (or using a mouse without a scroll wheel) and verifying that the correct plan is chosen before selecting OK on the Plan-of-the-Day form. This action has been closed-out on 02/02/2017.

Device

MOSAIQ 2.62 and higher with the IQ Scripts license enabled (Oncology information system used to m...
  • Model / Serial
    MOSAIQ 2.62 and higher with the IQ Scripts license enabled (Oncology information system used to manage workflows for treatment planning and delivery)ARTG Number: 206321
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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