Events

Recall of Brilliance iCT/iCT SP/Big Bore/6/10/16/16P/40/64 and Ingenuity CT/Core/Core128The following CT products manufactured from 1 January 2006 to 30 June 2014 are potentially affected:Brilliance iCT/Brilliance iCT SPBrilliance Big Bore Oncology/Brilliance Big Bore RadiologyBrilliance 6/Brilliance 10/Brilliance16/Brilliance 16P/Brilliance 40/Brilliance 64Ingenuity CT/Ingenuity Core/Ingenuity Core128

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-01470-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01470-1
  • 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
    The patient support table top may fail to move in the horizontal direction when it is commanded to do so during ct scans, due to a potential mechanical linkage failure. the system cannot automatically detect this failure to abort the scan or to alert the user. of the 5000 ct systems potentially affected, there have been 2 occurrences of this failure mode in the past 10 years. this issue could result in undesired radiation due to multiple exposures of the same anatomical region caused by failed couch motion during ct scanning.
  • Action
    A Philips Field Service Engineer will contact affected customers to schedule the updates. In the interim, customers are advised to follow the warning in the Instruction for Use: “During all movements of the gantry and the patient table (automatic and manual), keep the patient under continuous observation.” If the patient table is not moving when it is commanded to move during CT scan, abort the scan by pressing the Pause button or Emergency stop actuator and call the local Philips representative.

Device

Brilliance iCT/iCT SP/Big Bore/6/10/16/16P/40/64 and Ingenuity CT/Core/Core128The following CT pr...
  • Model / Serial
    Brilliance iCT/iCT SP/Big Bore/6/10/16/16P/40/64 and Ingenuity CT/Core/Core128The following CT products manufactured from 1 January 2006 to 30 June 2014 are potentially affected:Brilliance iCT/Brilliance iCT SPBrilliance Big Bore Oncology/Brilliance Big Bore RadiologyBrilliance 6/Brilliance 10/Brilliance16/Brilliance 16P/Brilliance 40/Brilliance 64Ingenuity CT/Ingenuity Core/Ingenuity Core128 ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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