Events

Recall of Brilliance CT and Ingenuity CT with software versions v4.13 and v4.1.4 (Computed tomography full-body 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-2016-RN-00340-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-03-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00340-1
  • 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 issue relates to the auto transfer to the remote devices (such as pacs), where there is a possibility for intermittent failures to send all images/data series automatically. the images remain on the local storage device until manually transferred to the remote device.
  • Action
    Philips is advising users of affected CT systems to assure that all images are transferred by checking that images are available on any remote devices before images/data series are deleted from local storage device. If there are missing images/data series on remote devices, the user can manually transfer images/data series to remote devices. Philips will be completing a software upgrade as a permanent fix. This action has been closed-out on 23/06/2017.

Device

Brilliance CT and Ingenuity CT with software versions v4.13 and v4.1.4 (Computed tomography full-...
  • Model / Serial
    Brilliance CT and Ingenuity CT with software versions v4.13 and v4.1.4 (Computed tomography full-body x-ray system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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