Events

Recall of Brilliance iCT and iCT SP up to and including Software Version 3.2.5

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-00766-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-07-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00766-1
  • 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
    When using 80kvp with intravenous contrast in head and neck studies with u-filters (ua, ub, uc), a vascular artefact that resembles thrombus may appear on the image. there is a risk of misdiagnosis which can lead to unnecessary treatment of a patient. for certain patient populations, this could contribute to serious injury.
  • Action
    When the settings (80 kVp with intravenous contrast in head and neck studies with U-filters (UA, UA and UC)) are used, Philips recommends performing additional reconstruction with a non-U filter and comparing the result images to verify no such artefact is evident. Customers are advised to continue to use 80 kVp with U-filters for brain perfusion scans. Refer to the Instructions for Use (IFU) for the selection of an arterial input unaffected by discontinuity should one occur.

Device

Brilliance iCT and iCT SP up to and including Software Version 3.2.5

Manufacturer

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