FDA Device recall Z-2502-2025

Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x)

FDA Device
Class II
ongoing
Published 2025-09-10

On 2025-09-10 the FDA classified a Class II recall of Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x) by Philips Medical Systems Nederland B V, citing philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2502-2025
Classification	Class II
Status	ongoing
Initiated	2025-08-01
Published	2025-09-10
Last updated	2026-09-13 11:57 UTC
Company	Philips Medical Systems Nederland B V
Distribution	US

Product

Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

Reason

Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

Identifiers

code_info	1. Model Number/System Code (UDI); Serial Numbers: 722063 (00884838085275); 25, 151, 91, 85, 90, 86, 107, 89, 88, 87, 1… 1. Model Number/System Code (UDI); Serial Numbers: 722063 (00884838085275); 25, 151, 91, 85, 90, 86, 107, 89, 88, 87, 120, 153, 96, 108. 2. Model Number/System Code (UDI); Serial Numbers: 722064 (00884838085282); 64, 260, 261, 335, 218, 267, 270, 258, 35, 10, 111, 82, 125, 94, 278, 36, 55, 12, 57, 69, 484, 451, 497, 155, 272, 490, 132, 70, 251, 226, 290, 186, 48, 373. 3. Model Number/System Code (UDI); Serial Numbers: 722067 (00884838085350); 150, 69, 221, 148, 42, 98, 123, 277, 92, 103, 41, 214, 173, 172, 163, 128, 151, 22, 23, 268, 112, 97, 243, 45, 108, 113, 127, 176, 165, 33, 30, 206, 203, 48, 149, 251, 262. 4. Model Number/System Code (UDI); Serial Numbers: 722068 (00884838085367); 213, 111, 85, 89, 320, 73, 308, 172, 295, 406, 285, 413, 322, 324, 184, 442, 279, 361, 490, 42, 103, 520, 470, 472, 457, 400, 547, 510, 239, 275, 265, 365, 481, 62, 552, 44, 158, 36, 276, 68, 551, 516, 372, 46, 185, 515, 347, 416, 242, 219, 299, 126, 211, 468, 238, 568, 583, 69, 60, 426, 427, 93, 3

code_info

1. Model Number/System Code (UDI); Serial Numbers: 722063 (00884838085275); 25, 151, 91, 85, 90, 86, 107, 89, 88, 87, 1…

1. Model Number/System Code (UDI); Serial Numbers: 722063 (00884838085275); 25, 151, 91, 85, 90, 86, 107, 89, 88, 87, 120, 153, 96, 108. 2. Model Number/System Code (UDI); Serial Numbers: 722064 (00884838085282); 64, 260, 261, 335, 218, 267, 270, 258, 35, 10, 111, 82, 125, 94, 278, 36, 55, 12, 57, 69, 484, 451, 497, 155, 272, 490, 132, 70, 251, 226, 290, 186, 48, 373. 3. Model Number/System Code (UDI); Serial Numbers: 722067 (00884838085350); 150, 69, 221, 148, 42, 98, 123, 277, 92, 103, 41, 214, 173, 172, 163, 128, 151, 22, 23, 268, 112, 97, 243, 45, 108, 113, 127, 176, 165, 33, 30, 206, 203, 48, 149, 251, 262. 4. Model Number/System Code (UDI); Serial Numbers: 722068 (00884838085367); 213, 111, 85, 89, 320, 73, 308, 172, 295, 406, 285, 413, 322, 324, 184, 442, 279, 361, 490, 42, 103, 520, 470, 472, 457, 400, 547, 510, 239, 275, 265, 365, 481, 62, 552, 44, 158, 36, 276, 68, 551, 516, 372, 46, 185, 515, 347, 416, 242, 219, 299, 126, 211, 468, 238, 568, 583, 69, 60, 426, 427, 93, 3

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2502-2025%22

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