Moderate riskFDA DeviceAug 12, 2026Class II

Philips Azurion X-ray systems recalled for potential imaging loss

Philips Medical Systems Nederland B.V. is recalling certain Azurion interventional X-ray systems. Unauthorized hard disk drives in these systems could cause a potential loss of imaging, loss of motorized movement, or loss of data.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

Set aside affected Azurion systems and check their system descriptions and model numbers against the list in the notice.
Contact Philips Medical Systems about the affected systems; the notice does not specify a remedy.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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.
Sold in: Nationwide
Made for: All ages (under 100 years)

This recall covers 3 products — see all of them.

Details

Units affected: 3,341 units
Illnesses reported: None reported
Manufactured in: Veenpluis 6, Best, Netherlands
Classification: Class II
Recall number: Z-2892-2026

In the FDA's words

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. Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. 1. Model Numbers (UDI Numbers): 722063 ((01)00884838085275(21)56, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)80, (01)00884838085275(21)146, (01)00884838085275(21)3, (01)00884838085275(21)22, (01)00884838085275(21)153, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)19, (01)00884838085275(21)121, (01)00884838085275(21)18, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)17, (01)00884838085275(21)53, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)151, (01)00884838085275(21)137, (01)00884838085275(21)73, (01)00884838085275(21)150, (01)00884838085275(21)105, (01)00884838085275(21)129, (01)00884838085275(21)59, (01)00884838085275(21)154, (01)00884838085275(21)75, (01)00884838085275(21)94, (01)00884838085275(21)26, (01)00884838085275(21)106, (01)00884838085275(21)135, (01)00884838085275(21)123, (01)00884838085275(21)89, (01)00884838085275(21)79, (01)00884838085275(21)133, (01)00884838085275(21)81, (01)00884838085275(21)140, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)148, (01)00884838085275(21)55), 722221 ((01)00884838099203(21)93, (01)00884838099203(21)108, (01)00884838099203(21)101, (01)00884838099203(21)124, (01)00884838099203(21)4, (01)00884838099203(21)106, (01)00884838099203(21)151, (01)00884838099203(21)71, (01)00884838099203(21)105, (01)00884838099203(21)60, (01)00884838099203(21)33, (01)00884838099203(21)55, (01)00884838099203(21)44, (01)00884838099203(21)74, (01)00884838099203(21)142, (01)00884838099203(21)144, (01)00884838099203(21)147, (01)00884838099203(21)96, (01)00884838099203(21)92, (01)00884838099203(21)78, (01)00884838099203(21)23, (01)00884838099203(21)133, (01)00884838099203(21)167, (01)00884838099203(21)26, (01)00884838099203(21)15, (01)00884838099203(21)163, (01)00884838099203(21)67, (01)00884838099203(21)81, (01)00884838099203(21)22). 2. Model Numbers (UDI Numbers): 722064 ((01)00884838085282(21)258, (01)00884838085282(21)229, (01)00884838085282(21)291, (01)00884838085282(21)270, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)335, (01)00884838085282(21)513, (01)00884838085282(21)297, (01)00884838085282(21)169, (01)00884838085282(21)479, (01)00884838085282(21)359, (01)00884838085282(21)220, (01)00884838085282(21)375, (01)00884838085282(21)173, (01)00884838085282(21)502, (01)00884838085282(21)157, (01)00884838085282(21)130, (01)00884838085282(21)60, (01)00884838085282(21)263, (01)00884838085282(21)264, (01)00884838085282(21)253, (01)00884838085282(21)254, (01)00884838085282(21)280, (01)00884838085282(21)102, (01)00884838085282(21)461, (01)00884838085282(21)510, (01)00884838085282(21)345, (01)00884838085282(21)185, (01)00884838085282(21)193, (01)00884838085282(21)271, (01)00884838085282(21)214, (01)00884838085282(21)212, (01)00884838085282(21)266, (01)00884838085282(21)213, (01)00884838085282(21)180, (01)00884838085282(21)431, (01)00884838085282(21)354, (01)00884838085282(21)374, (01)00884838085282(21)106, (01)00884838085282(21)58, (01)00884838085282(21)288, (01)00884838085282(21)231, (01)00884838085282(21)287, (01)00884838085282(21)150, (01)00884838085282(21)380, (01)00884838085282(21)233, (01)00884838085282(21)230, (01)00884838085282(21)44, (01)00884838085282(21)197, (01)00884838085282(21)176, (01)00884838085282(21)149, (01)00884838085282(21)289, (01)00884838085282(21)448, (01)00884838085282(21)82, (01)00884838085282(21)323, (01)00884838085282(21)35, (01)00884838085282(21)55, (01)00884838085282(21)45, (01)00884838085282(21)40, (01)00884838085282(21)125, (01)00884838085282(21)484, (01)00884838085282(21)36, (01)00884838085282(21)104, (01)00884838085282(21)155, (01)00884838085282(21)422, (01)00884838085282(21)132, (01)00884838085282(21)67, (01)00884838085282(21)439, (01)00884838085282(21)446, (01)00884838085282(21)138, (01)00884838085282(21)293, (01)00884838085282(21)292, (01)00884838085282(21)379, (01)00884838085282(21)321, (01)00884838085282(21)520, (01)00884838085282(21)519, (01)00884838085282(21)208, (01)00884838085282(21)462, (01)00884838085282(21)342, (01)00884838085282(21)222, (01)00884838085282(21)391, (01)00884838085282(21)98, (01)00884838085282(21)441, (01)00884838085282(21)320,
Hazard: Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

3 products in this recall

Philips Allura, Azurion X-ray systems recalled for hard drive risk

Philips is recalling 3 interventional X-ray system lines, sold as Philips Allura (including Allura Xper FD10 and Allura Centron), Philips Azurion, and Allura Centron, with about 8,610 units affected. The systems may contain unauthorized hard disk drives, which could cause loss of imaging, loss of motorized movement, or loss of data. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Al…
Z-2891-2026 · 5,012 units
Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M1… (this page)
Z-2892-2026 · 3,341 units
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Z-2893-2026 · 257 units