Events

Recall of Brilliance iCT with Software Version 4.1.0.19260

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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-2013-RN-01333-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01333-1
  • 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
    Philips has detected a situation where ring artifacts may occur. the conditions that may create these specific ring artifacts occur when a user:1. selects a non-gated helical scan with automatic scan time on 2. they edit the preview images using ‘edit before final recon’ (reconstruction); and,3. the automatic scan time algorithm is executed after the scan has been acquired.Presence of ring artifacts affecting diagnostic quality of images may result in a rescan.
  • Action
    To avoid the occurrence of these specific ring artifacts users can implement the following work around: 1. Disable Automatic Scan Time for all Exam Cards 2. Leave Automatic Scan Time on during planning and prior to clicking 'Go' to initiate the scan, click the acquisition series of the scan and disable Automatic Scan Time, then proceed with the scan. 3. Disable Edit Before Final Reconstruction for all Exam Cards. If ring artifact is present clinical judgement should be used to determine if rescan is required. A software update will be implemented to correct the problem.

Device

Brilliance iCT with Software Version 4.1.0.19260

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA