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TGA Action ID	RC-2026-RN-00081-1
Type of Product	Medical Device
Product Name/Description	Spectral CT Product Code: 728333
ARTG Number	423851
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled, resulting in a potential risk of serious injury, including death, to individuals in the scanning room. As of December 2025, Philips has received two (2) complaints related to this problem. In both instances, no parts were expelled from the gantry, and no injuries or harm occurred.
Instructions for Customers/Users	Philips will contact customers to schedule a time for a Philips Field Service Engineer (FSE) to visit their site and to inspect the fasteners on their system (reference FCO72800845). If the inspection indicates that their system is affected, Philips will perform the correction to resolve the problem (reference FCO72800846). This action has been closed out on 11/05/2026
Action Commencement Date	2/02/2026
Responsible Entity	Philips Electronics Australia Ltd
Contact Information	Philips Service Delivery Team: 1800 251 400