Events

Recall of Philips Brilliance iCT/iCT SP with software version 4.1.3, 4.1.5

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-2016-RN-00680-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00680-1
  • 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 became aware of certain issues with the affected products through testing & customer feedback. the identified issues include;- imr cardiac - irregular appearance of contrast in vessels;- missing image annotations in cct- halo artefacts- incorrect z annotation on plan box for coronal/sagittal surviews- post injection delay between timed scans may be inaccurate- unintended change of acquisition timing on scan ruler- bolus tracker does not trigger as expected- cardiac step & shoot stops after arrhythmia detected- tracker scan halted with fdom- error when auto roi placement outside patient anatomy- no "go" when hr outside acceptable range- unplanned results during multi-phase pulmo series, may cause a system crash- dynamic myocardial perfusion acquisition halted after 1st shot- double clicking ecg phase bar crashes exam application- incorrect phase tolerance for cardiac s&s; &- ring artefacts on high resolution images, idose4 & imr.
  • Action
    Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 24/05/2017.

Device

Philips Brilliance iCT/iCT SP with software version 4.1.3, 4.1.5

Manufacturer

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