Events

Recall of Brilliance CT and Ingenuity CT systems with software version v4.1.3 and v4.1.4

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-00637-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-05-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00637-1
  • 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
    On the affected ct systems and software versions, varian rpm drive is not mapped in ct user profile after logout/login. the map drive utility maps the varian drive using full varian credentials in the service login and then creates a script that maps it with full varian credentials in the ct user login. once the script has run in the ct login and the user acknowledges the drive mapped successfully, the script deletes itself. on subsequent logins, the drive will not connect because the varian credentials are no longer available. should this situation occur, the user will be unable to perform pulmonary gated scans.
  • Action
    Philips is advising users to contact Service to login to service mode to reconnect Varian RPM drive. Philips is implementing a software upgrade as a permanent correction. This action has been closed out on 15 June 2017.

Device

Brilliance CT and Ingenuity CT systems with software version v4.1.3 and v4.1.4

Manufacturer

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