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TGA Action ID	RC-2026-RN-00506-1
Type of Product	Medical Device
Product Name/Description	Affera Prism-2 Integrated Mapping System Software Versions: 2.3.1, 2.3.2 Model Number: AFR-00016
ARTG Number	522206
Unique Device Identifier (UDI)	00763000998288
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Medtronic has identified multiple software problems in the Affera Prism-2 Integrated Mapping System. The affected software may not perform as intended, potentially resulting in loss of case data, mapping inaccuracies, temporary loss of functionality, procedure delays, system instability, or failure of the application to launch following data corruption after a hard reboot.
Instructions for Customers/Users	Customers are to coordinate with Medtronic to arrange and provide access for the software update of affected devices.
Action Commencement Date	3/07/2026
Responsible Entity	Medtronic Australasia Pty Ltd
Contact Information	0417 406 225 - Alex Jackson (Medtronic)