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TGA Action ID	RC-2026-RN-00090-1
Type of Product	Medical Device
Product Name/Description	MR systems Software Version: R5.2 through R5.8.1 Models: SmartPath to dStream for 1.5T, Ingenia Elition S, SmartPath to Ingenia Elition X, Intera 1.5T Achieva Nova, SmartPath to dStream for XR and 3.0T, Ingenia 3.0T CX, Ingenia 1.5T, Ingenia 3.0T, Ingenia Ambition X, Ingenia Elition X, Ingenia 3.0T, Ingenia 1.5T, Ingenia Elition S, Ingenia Ambition S Product Codes: 781260, 781357, 782118, 781172, 781270, 781271, 781341, 781342, 781356, 781358, 781377, 781396, 782106, 782108
ARTG Number	230064, 485786
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Philips has identified that MRI images may display an incorrect orientation, where the patient’s hands are reversed showing the left hand as the right and the right hand as the left. This problem may occur if both of the following conditions are met: • The patient is head-first (head facing the bore of the MRI scanner) in the superman-prone or superman-supine position with both hands raised over their head and placed inside a coil. • The exam is set up for prone position (laterality set to ‘both’; anatomic region set to ‘hand (arm)’). Philips has identified additional software defects that have no associated safety impact but may impact clinical workflow, as mentioned in the customer letter. These are being implemented to ensure compliance to regulatory standard IEC 60601-2-33 4th edition with no changes to clinical functionality. As of September 2025, Philips has received no reports of adverse events associated with these problems.
Instructions for Customers/Users	Customers may continue to use their system(s) in accordance with the intended use. • To avoid the potential problem of incorrect orientation, set laterality to ‘unpaired’ or perform an exam where only a single hand is scanned with laterality set to ‘left’ or ‘right’. • Circulate this notice to all users of this device so that they are aware of the problems and software upgrades. Philips will contact customers to schedule time for a Field Service Engineer (FSE) to install a software upgrade to resolve the software problems. Corrections are available. This action has been closed out on 21/09/2026
Action Commencement Date	9/02/2026
Responsible Entity	Philips Electronics Australia Ltd
Contact Information	1800 251 400 - Philips Service Delivery Team