Events

Recall of Brilliance CT 16, 64, Big Bore iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core128, 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-2014-RN-00474-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00474-1
  • 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
    Philips have found two potential issues that may result in the subframe of the table top becoming free floating and causing unintended, horizontal motion. the two potential issues are:1. service latch may not be properly secured;2. service latch threaded rod may be fractured.There is a risk of serious injury to the patient and operator/technician as a result of the table top free floating. for the patient:· there is a potential for disconnection or movement of invasive medical devicesfor the operator/technician:· there is a potential for pinch point on the subframe; and a potential for entrapment between the table and the gantry if the operator/technician stands between them to shift the patient forward.
  • Action
    Philips is advising their customers to stop using the system if horizontal free-floating couch motion is experienced during normal clinical use. The threaded rob will be replaced in all affected devices. This action has been closed-out on 12/02/2016.

Device

Brilliance CT 16, 64, Big Bore iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex

Manufacturer

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