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TGA Action ID	RC-2025-RN-00726-1
Type of Product	Medical Device
Product Name/Description	HEYEX 2 / HEYEX PACS From version 2.6.0 (Build 2088) to 2.6.8 (Build 2220)
ARTG Number	373496
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	In the Multi Modality Viewer, when using the freeform measurement function, the measured area value may be smaller than the actual area. Detectability of this error by the user is low. Undersized measurements could potentially misinform clinical decisions that rely on lesion size. Measurement errors may influence treatment decisions, potentially leading to delays, reduction or cessation of treatment. All other measurement functions in HEYEX 2 / HEYEX PACS, including in the Multi Modality Viewer, are not affected and can be used.
Instructions for Customers/Users	Customers are to inspect their software version immediately to determine if their device is affected (instructions are provided in the customer letter). If their device is affected customers are to stop using the freeform measurement tool in the Multi Modality Viewer. Contact Heidelberg Engineering on (03) 9639 2125 to arrange for the updated software version 2.6.9. This action has been finalised on 19/3/2026.
Action Commencement Date	19/08/2025
Responsible Entity	Heidelberg Engineering Pty Ltd
Contact Information	(03) 9639 2125 - Heidelberg Engineering