Events

Recall of Philips Brilliance 64 and Ingenuity CT, Core, Core128 with software version 4.1.6.XX030

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-01196-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01196-2
  • 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
    While performing high resolution head scans, the reconstructed images may exhibit degraded image quality manifested as:- non uniformity of the image, - ct number shift, greater than 5 hounsfield units,- reduction in grey/white matter differentiation. the issue is most severe in the high resolution mode. philips provides factory reference paediatric scan protocols which are set to high resolution by default. adult head scans have a factory reference protocol that defaults to standard resolution which does not experience the issue.
  • Action
    Philips is advising users to perform head scan with standard resolution across all patient populations on systems running the affected software. Philips will be implementing a software correction as a permanent correction. This action has been closed-out on 15/03/2018.

Device

Philips Brilliance 64 and Ingenuity CT, Core, Core128 with software version 4.1.6.XX030
  • Model / Serial
    Philips Brilliance 64 and Ingenuity CT, Core, Core128 with software version 4.1.6.XX030ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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