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TGA Action ID	RC-2026-RN-00835-1
Type of Product	Medical Device
Product Name/Description	MR Systems on R12.3.0 and R12.3.1 Model Names: Ingenia 3.0T CX, Ingenia 1.5T, Ingenia 3.0T, Ingenia Elition S 3.0T, Ingenia Elition X 3.0T, Ingenia 3.0T, Ingenia Elition S, Ingenia Elition X, Ingenia Ambition S, Ingenia Ambition X,SmartPath to Ingenia Elition X, Ingenia Ambition X, Ingenia Ambition S, MR 7700 Model Numbers: 781271, 781341, 781342, 781357, 781358, 781377, 782106, 782107, 782108, 782109, 782118, 782138, 782139, 782155
ARTG Number	230064, 485786
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class III
Reason for the Action	Philips has identified multiple software problems affecting MR systems on software versions R12.3.0 and R12.3.1. The problems have no associated safety impact and do not prevent the system from functioning in accordance with the intended use; however, they can cause inconvenience for operators.
Instructions for Customers/Users	Customers can continue to use the system in accordance with the intended use. Philips will contact customers to schedule time for a Field Service Engineer (FSE) to install software R12.3.2 SP1 (Reference 2026-PD-MR-018). The expected release date of the software is 31/12/2026.
Action Commencement Date	19/10/2026
Responsible Entity	Philips Electronics Australia Ltd
Contact Information	1800 251 400 - Philips Service Delivery Team