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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