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
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The hazard
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
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.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model (01)00884838085275(21)96Model (01)00884838085275(21)98Model (01)00884838085275(21)80Model (01)00884838085275(21)146Model (01)00884838085275(21)3Model (01)00884838085275(21)22Model (01)00884838085275(21)153Model (01)00884838085275(21)40Model (01)00884838085275(21)70Model (01)00884838085275(21)30Model (01)00884838085275(21)19Model (01)00884838085275(21)121Model (01)00884838085275(21)18Model (01)00884838085275(21)16Model (01)00884838085275(21)14Model (01)00884838085275(21)17Model (01)00884838085275(21)53Model (01)00884838085275(21)101Model (01)00884838085275(21)143Model (01)00884838085275(21)41Model (01)00884838085275(21)104Model (01)00884838085275(21)151Model (01)00884838085275(21)137Model (01)00884838085275(21)73Model (01)00884838085275(21)150UPC 00884838085275Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.