Events

Recall of Brilliance iCT/iCP SP, CT 64, Ingenuity CT/Core/Core 128 with software version 4.1.6

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-2017-RN-01235-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01235-1
  • 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 have identified that upon completion of the scan procedure during bolus tracking on a brilliance ict with software version 4.1.6, no images were generated. this leads to unavailability of raw data for offline reconstruction.This issue always leads to ct rescan.
  • Action
    Philips Healthcare is advising users that a Field Service engineer will perform an update to the system to correct the issue.

Device

Brilliance iCT/iCP SP, CT 64, Ingenuity CT/Core/Core 128 with software version 4.1.6
  • Model / Serial
    Brilliance iCT/iCP SP, CT 64, Ingenuity CT/Core/Core 128 with software version 4.1.6ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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