| TGA Action ID |
RC-2026-RN-00097-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Azurion R3.0 Systems
Product Descriptions: Azurion 7 M12, Azurion 7 M20, Azurion 7 B20
Model Numbers: 722233, 722234, 722236 |
| ARTG Number |
370112 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Philips has identified nine software problems affecting Azurion R3.0 systems that may result in loss of imaging (X-ray) functionality, and/or loss of motorised movement, and/or incorrect image content, and/or loss of data.
Problem 1 - Loss of X-ray after Pedal Tap
Problem 2 - Loss of X-ray after Phase Fault
Problem 3 - Missing live X-ray on the FlexVision monitor
Problem 4 - System keeps restarting
Problem 5 - AMC triple drive
Problem 6 - C-Partition of Suite PC running out of free space
Problem 7 - System remains in continuous restart mode after the start-up
Problem 8 - Misalignment of Marker Tool Overlay
Problem 9 - Longitudinal Position Error
The potential problems may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings). |
| Instructions for Customers/Users |
Customers should read the Customer Letter that outlines all the steps to mitigate these problems whilst awaiting a fix, which may include a cold restart.
Philips expects to have software update 3.1.5, that resolves problems 1 - 7, released by Q1 2026 (subject to regulatory clearance).
The Misalignment of Marker Tool Overlay (problem 8) and Longitudinal Position Error (problem 9) will not be resolved with software update 3.1.5. The solution for those problems is planned for Q4 2026 (subject to regulatory clearance) with software update 3.1.15.
UPDATE 11/8/2026: Philips had previously communicated in Feb 2026 that problems 1–7 would be corrected through software update R3.1.5, expected to be available in Q1 2026, and that problems 8–9 would be corrected through software update R3.1.15, expected to be available in Q4 2026.
Philips now expects software update R3.1.15 to be available by October 2026, subject to regulatory clearance. |
| Action Commencement Date |
11/02/2026 |
| Responsible Entity |
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| Contact Information |
1800 251 400 - Philips Service Delivery Team |