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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00066-1
Product Name/Description Ingenuity CT/Core/Core128/Flex, Brilliance CT Big Bore /iCT/iCT SP Systems

Affected Models:

728306 – Brilliance iCT
728311 – Brilliance iCT SP
728326 – Ingenuity CT
728321 – Ingenuity Core
728323 – Ingenuity Core128
728317 – Ingenuity Flex
728244 – Brilliance CT BigBore (Radiology)
728243 – Brilliance CT BigBore (Oncology)

ARTG Number: 98868
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 15/01/2016
Responsible Entity Philips Electronics Australia Ltd
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.
This action has been closed-out on 19/03/2018.
Contact Information 1800 251 400 - Philips Customer Care Centre