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TGA Action ID	RC-2026-RN-00774-1
Type of Product	Medical Device
Product Name/Description	HAMILTON-C6 Ventilator Product Code: HMT-160021 Part Number: 160021 Software Version: v2.0.1
ARTG Number	113999
Unique Device Identifier (UDI)	07630002808590
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Hamilton Medical has identified several software problems that may occur under specific operating conditions in devices running software version 2.0.1. These problems may result in false disconnection alarms, temporary panel reboots, unsuccessful flow sensor calibration, or the ventilator continuing to apply a previous pressure limit (Plimit) setting after certain ventilation mode changes. To date, no reports of patient harm, serious injury, or death related to these problems have been received.
Instructions for Customers/Users	Customers are to identify all devices operating with software version 2.0.1 within their facility and continue using affected devices in accordance with the precautions outlined in the customer letter while awaiting installation of software version 2.0.2.
Action Commencement Date	2/10/2026
Responsible Entity	Device Technologies Australia Pty Ltd
Contact Information	1300 338 423 - Device Technologies Australia