Events

Recall of Brilliance 64, software version 4.0.0.22621 and Ingenuity CT, software version 4.0.025621 (Whole body computed tomography x-Ray systems)

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-00197-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-03-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00197-1
  • 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
    1- swirl-like ring artifacts may appear on reconstructed images impairing the diagnostic quality.2- when executing two bolus scans the system may freeze during the second tracker execution, impacting countdown timer displayed to the user which indicates the start of the clinical scan. 3- there are inconsistencies between the gui and the instructions for use (ifu)/technical reference guide (trg): english version 459800340361_a documentation for the (qa) testing4- teflon and other pins hu values are incorrectly documented in the ifu/trg.
  • Action
    Philips is provided information and work around instructions to mitigate some of the issues. A software update and revision of the Instructions for Use (IFU) documentation will be implemented to correct the issue.

Device

Brilliance 64, software version 4.0.0.22621 and Ingenuity CT, software version 4.0.025621 (Whole ...
  • Model / Serial
    Brilliance 64, software version 4.0.0.22621 and Ingenuity CT, software version 4.0.025621 (Whole body computed tomography x-Ray systems)ARTG: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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