Events

Recall of iGUIDE software 2.2(sites using iGUIDE 2.2.0 and 2.2.1)

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-00802-1
  • Event Risk Class
    Class I
  • 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-00802-1
  • 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 that if the pec data dialog after a verification scan is cancelled, a re-send of pec data will lead to incorrect positioning because the 2nd pec values supersede the 1st pec values instead of being added. there is a risk of incorrect positioning (values of 1st pec are overwritten).
  • Action
    Elekta is requesting that users do not cancel the 2nd iGUIDE PEC data dialog (and confirm the cancellation) for a verification scan. If you have cancelled the 2nd PEC data dialog, you have to restart the positioning and return to the beginning of the positioning procedure.

Device

iGUIDE software 2.2(sites using iGUIDE 2.2.0 and 2.2.1)
  • Model / Serial
    iGUIDE software 2.2(sites using iGUIDE 2.2.0 and 2.2.1)Reference Number: FCA-MI-0003ARTG Number 187340
  • Product Classification
    Radiology Devices
  • Manufacturer
    Elekta Pty Ltd

Manufacturer

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