Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Device class: 2
Device name: Interventional Fluoroscopic X-Ray System
Event initiated: 2026-06-17
FDA posted: 2026-08-05
Recall ID: Z-2892-2026
Product: Philips Azurion under the following System Descriptions and corresponding model numbers:
1. Azurion 3 M12; Model Numbers: 722063, 722221.
2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280.
3. Azurion 5 M12; Model Number: 722227.
4. Azurion 5 M20; Model Numbers: 722228, 722281.
5. Azurion 7 B12; Model Numbers: 722067, 722225.
6. Azurion 7 B20; Model Numbers: 722068, 722226.
7. Azurion 7 M12; Model Numbers: 722078, 722223.
8. Azurion 7 M20; Model Numbers: 722079, 722224, 722282.
Interventional Fluoroscopic X-Ray System.
Reason for recall
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.