Events

Recall of Brilliance 64 and Ingenuity CT systems with software version 4.0.0.xx379 (Full body diagnostic CT 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-2012-RN-00812-3
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00812-3
  • 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
    The following issues have been identified with this product:1. the current system design of software version 4.0.0.Xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for ct brain perfusion scanning, which previous versions did. however, the current version does have the dose check (nema xr-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable dose check after entering their credentials and password 2. when service providers gain a remote connection to the scanner, the scanner does not notify the user that remote access of the system is in effect3. when the interventional biopsy protocol is used, the manual button is enabled on the ct control, but when the user presser the "go" button on the gantry, it may produce multiple scans4. the table and the gantry could get close enough to each other (<25mm apart) which poses the risk of 'pinching' a patient's or technologist's finger.
  • Action
    Philips is providing a software update to permanently correct the issues.

Device

Brilliance 64 and Ingenuity CT systems with software version 4.0.0.xx379 (Full body diagnostic CT...

Manufacturer

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