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FDA · Medical devices ·

Philips Azurion under the following System Descriptions and corresponding model numbers recall

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled Philips Azurion under the following System Descriptions and corresponding model numbers on August 12, 2026 because of potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. It was sold nationwide.

Why it was recalled

Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.

What's recalled

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.

Quantity: 3,341 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
US Nationwide distribution.
Status
Ongoing
Recall number
Z-2892-2026
Source
U.S. Food and Drug Administration

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