Events

Recall of Brilliance CT 16 Air, 64, Big Bore, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128 and Ingenuity Flex

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-2015-RN-00031-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00031-1
  • 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
    A potential problem with the vertical motor / brake assembly on a manufacturing lot of the patient support / couch was discovered, which may result in uncommanded vertical patient support / couch motion.
  • Action
    End users are advised that when preparing and operating the device end users are advised to take extra caution while the patient is near the patient support. If any un-commanded motion is experienced end users are requested to discontinue use of the device and to contact their local service provider. A Philips Field Service Engineer will service your system to resolve the issue. This action has been closed-out on 15/07/2016.

Device

Brilliance CT 16 Air, 64, Big Bore, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128 ...
  • Model / Serial
    Brilliance CT 16 Air, 64, Big Bore, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128 and Ingenuity FlexARTG number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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