Events

Recall of Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP Systems

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-00066-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00066-1
  • 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 identified an issue due to hydrogen embrittlement of fasteners during manufacture of ct systems. it was determined the issue was due to trapped hydrogen introduced into the fastener during electroplating operations performed by a philips supplier. hydrogen embrittled fasteners can crack and fail suddenly when under stress. assessment of these fasteners determined that sufficient mitigations were in place such that a single-point failure did not exist. even should two fasteners fail for the same component, the occurrence of harm was determined to be less than remote. there have been no complaints associated with this issue, and no reports of injury or death.
  • Action
    Philips will replace the affected service latch fasteners for the units in the field. Philips is advising customers that in the interim, the affected CT systems have been determined to be safe for continued use.

Device

Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP Systems
  • Model / Serial
    Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP SystemsAffected Models:728306 – Brilliance iCT728311 – Brilliance iCT SP 728326 – Ingenuity CT728321 – Ingenuity Core728323 – Ingenuity Core128728317 – Ingenuity Flex728244 – Brilliance CT BigBore (Radiology)728243 – Brilliance CT BigBore (Oncology)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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