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 |
|
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 |