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TGA Action ID	RC-2025-RN-00385-1
Type of Product	Medical Device
Product Name/Description	Radiography 7000 M Model number: 712010
ARTG Number	451166
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Software start-up defects associated with Radiography 7000 M systems may occur when software is reinstalled on the system after initial setup (due to file corruption, etc.). After reinstallation of software, a recovery mode screen may be displayed at system start-up, preventing use of the system. If reinstallation of software is required, Philips trained personnel currently have a work-around in place to prevent this problem from occurring. Therefore, no additional systems should experience this problem. Philips has also identified additional software problems that may impact clinical workflow. In an emergency where no alternative backup systems or imaging modalities are available for a timely diagnosis, there is a potential for a delay in diagnosis. Philips has not received any reports of injury related to these problems to date.
Instructions for Customers/Users	Customers are to: • Continue to use the system(s) in accordance with the intended use. • Retain the Product Correction notice with their system(s) until the software upgrade is installed. A Philips representative will contact customers to schedule a time for a Field Service Engineer (FSE) to implement a software solution to resolve the problems. This action has been closed out on 20/07/2026
Action Commencement Date	11/04/2025
Responsible Entity	Philips Electronics Australia Ltd
Contact Information	1800 251 400 - Philips Service Delivery Team