Events

Recall of Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 728332) Scanner systems Manufactured beginning May 2009

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-2017-RN-01454-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-12-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01454-1
  • 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
    There is a possibility that screws holding an internal portion of the gantry (reaction ring) to the scanner’s main bearing may come loose. if this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry. there is no potential for harm to the patient or operator due to this issue.
  • Action
    Philips is advising users that they will be inspecting the affected systems, tightening and replacing the reaction ring screws as needed at no additional cost. (Reference: Field Correction FCO 72800690)

Device

Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 72833...
  • Model / Serial
    Brilliance iCT (Model 728306), Brilliance iCT SP (Model 728311) and IQon Spectral CT (Model 728332) Scanner systemsManufactured beginning May 2009ARTG: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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