Events

Recall of Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance 64, Brilliance iCT SP, Brilliance iCT systems with software versions 4.1.2, 4.1.3 and 4.1.4

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-2015-RN-01163-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01163-1
  • 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, the perfusion scan feature may be unavailable. no harm has been reported, and no potential harm because of unavailability of the scanner feature.
  • Action
    A software update will be released to correct the issue by Philips. A Philips Field Service Engineer will contact customers to schedule the software update installation at their site. This action has been closed-out on 04/07/2017.

Device

Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance 64, Brilliance iCT SP, Brilliance iCT...
  • Model / Serial
    Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance 64, Brilliance iCT SP, Brilliance iCT systems with software versions 4.1.2, 4.1.3 and 4.1.4 ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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