Events

Recall of Brilliance 64 system with software version 4.00xx516 and Ingenuity CT system running software version 4.00xx518 (full body CT systems)

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-01187-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01187-1
  • 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
    1. during an interventional procedure with an interventional exam card reconstruction increment set to a negative value, one exposure of cct was not reconstructed – there was radiation but images were not updated on the screen. 2. when moving the couch using the gantry buttons during an interventional procedure & the user chooses an interventional exam card with the reconstruction increment set to a negative value, the user has to wait a few seconds for the new position to update. there is an image update delay at about 5 second intervals. 3. when reconstructing images with o-mar the system may fail to provide a non-omar set of images as required. the non-omar images must be manually reconstructed. 4. the rotor begins to spin without waiting for service personnel to request the go command. 5. incorrect cbv values in the brain perfusion application may occur if the user takes brain perfusion images from a ge scanner into a specific application installed on a philips scanner.
  • Action
    Philips is provided work around instructions for the issue and will be implementing a software update to correct the problem.

Device

Brilliance 64 system with software version 4.00xx516 and Ingenuity CT system running software ver...
  • Model / Serial
    Brilliance 64 system with software version 4.00xx516 and Ingenuity CT system running software version 4.00xx518 (full body CT systems)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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