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Medical Device

Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221.

Recall date: 2026-08-12 · Source: FDA_DEVICE
Brand / Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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.
Units affected
3,341 units
Description
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.
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