Events

Recall of Brilliance CT Big Bore with Software Versions 2.4.7 or 2.4.8 (Full body CT system)

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-2012-RN-01009-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01009-1
  • 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 healthcare has received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. the problem can occur when the scan was in "ready to scan" or scanning mode. there is a risk of undesired radiation due to the potential for a rescan if this issue happened during scanning mode.
  • Action
    Philips Healthcare will be installing a software update to address the identified issue.

Device

Brilliance CT Big Bore with Software Versions 2.4.7 or 2.4.8 (Full body CT system)

Manufacturer

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