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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbe
Recalled August 12, 2026 · FDA recall Z-2892-2026 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V
Hazard
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. · FDA Class II
Units
3,341 units
Sold at
US Nationwide distribution.
Description
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
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.
Manufacturer(s)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →