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TGA Action ID	RC-2026-RN-00355-1
Type of Product	Medical Device
Product Name/Description	Philips Azurion and Allura Systems Systems: Allura Xper FD10, Allura Xper FD20, ALLURA XPER FD20 BIPLANE, Allura Xper FD20 OR Table, Allura Xper FD10/10, Allura Xper FD20/15, Azurion 7 B12, Azurion 7 B20, Azurion 7 M12, Azurion 7 M20, Azurion 5 M12 System Codes: 722006, 722010, 722012, 722013, 722023, 722026, 722027, 722028, 722035, 722058, 722067, 722068, 722078, 722079, 722227
ARTG Number	225815
Unique Device Identifier (UDI)	N/A
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Philips has identified that Hard Disk Drives (HDDs) used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Problems with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorised movement, or loss of data. In some cases, a system restart may temporarily restore functionality. Philips has not received any reports of harm associated with this problem.
Instructions for Customers/Users	Philips will replace the HDDs in all affected systems. Philips expects to start replacing the HDDs in September 2026. A local Philips representative will contact customers to schedule a visit to replace the HDDs in systems. In the meantime, in case motorised movements are unavailable, the stand can be manually repositioned using the handgrips and brake controls located on both sides of the stand. More information is available in the customer letter.
Action Commencement Date	12/05/2026
Responsible Entity	Philips Electronics Australia Ltd
Contact Information	1800 251 400 - Philips Service Delivery Team