Events

Recall of Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions: (Computed tomography (CT) full-body diagnostic X-ray 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-2015-RN-00755-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00755-1
  • 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
    Some scans unexpectedly set the axial (z axis) scan length to a greater length than the user set in the plan.The issue occurs only when the following 3 conditions are met:· the plan employs dual-surview· the plan requests either a sagittal or a coronal reconstruction.· the gantry is tilteddue to this issue, there is a potential for undesired radiation to areas not intended to be scanned.
  • Action
    Philips is developing a new version of software that will eliminate the defect. Deployment of this new software will begin before the end of April, 2016. All customers will be updated by the end of October, 2016. In the interim, to eliminate the possibility of the defect from occurring, the user can eliminate any one of the three conditions (identified above) needed to trigger the behaviour. If the user chooses to eliminate the reconstruction from the plan, then that reconstruction can be created after the scan is complete. This action has been closed out on 15 June 2017.

Device

Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions: (...
  • Model / Serial
    Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 with the following versions: (Computed tomography (CT) full-body diagnostic X-ray system)4.0.x.xxxx – Any version of 4.04.1.y.xxxx – Only version up to and including 4.1.4.ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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