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TGA Action ID RC-2025-RN-00757-1
Type of Product Medical Device
Product Name/Description Philips Azurion and Allura with 1 Phase UPS

Product Names: Allura Xper FD10, Allura Xper FD10/10, Allura Xper FD20 OR Table, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20, Azurion 3 M12, Azurion 7 M12, Azurion 7 M20, Azurion 7 B20, Azurion 5 M12, Azurion 5 M20

Product Codes: 722026, 722027, 722035, 722067, 722068, 722078, 722079, 722221, 722223, 722224, 722226, 722227, 722228
ARTG Number 225815, 370112
Action Type Product Correction
Action Level Hospital
Hazard Classification Class II
Reason for the Action Philips has identified that some internal components of the 1 Phase UPS may fail. When this occurs, there will be a complete loss of power to the system, causing the system to shut down and/or not start up. The 1 Phase UPS system may fail without warning and prior to any mains power failure.

If the system does not start up or the system shuts down, there is a potential risk of delay or termination of the procedure. The potential delay in treatment and/or termination of the procedure may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with critical patients.

In the period from January 2022 to May 2025, Philips has received 153 complaints related to Azurion systems and 32 complaints related to Allura systems associated with this problem. None of these complaints reported any harm to the patient.
Instructions for Customers/Users Customers are to:
- Continue to use affected systems in accordance with their Instructions for Use.
- Establish an emergency protocol prior to all procedures to manage the situation should you experience the problem during a procedure.
- Philips will contact all affected customers to schedule the corrective activity. Philips expects to start bypassing the 1 Phase UPS by Q4 2025.
Action Commencement Date 16/09/2025
Responsible Entity Philips Electronics Australia Ltd
Contact Information 1800 251 400 - Philips Electronics Australia