Class II U.S. Food and Drug Administration

Philips Azurion System configured with a 1 Phase UPS. Azurion family recall: Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible

Recall published 1+ years ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2502-2025
Published
September 10, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Philips Medical Systems Nederland B.v.
Product type
Medical devices
Units affected
1,861 units
Distribution
Nationwide
Made in
Netherlands
Lot / code info
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, 303, 302, 141. 5. Model Number/System Code (UDI); Serial Numbers: 722078 (00884838085251); 465, 143, 278, 402, 290, 524, 412, 166, 539, 532, 291, 415, 753, 441, 305, 289, 803, 399, 536, 537, 478, 479, 224, 163, 719, 364, 239, 383, 829, 513, 661, 215, 677, 709, 410, 269, 185, 902, 360, 546, 294, 906, 603, 870, 523, 598, 317, 535, 359, 436, 165, 733, 218, 204, 205, 206, 888, 923, 197, 195, 797, 444, 222, 489, 361, 362, 30, 223, 584, 962, 893, 27, 977, 156, 909, 953, 182, 958, 847, 959, 610, 490, 103, 184, 506, 23, 112, 199, 1047, 1074, 850, 643, 319, 547, 879, 572, 38, 865, 881, 261, 472, 368, 369, 243, 244, 731, 202, 442, 351, 636, 777, 40, 477, 134, 341, 563, 633, 286, 336, 512, 158, 357, 397, 896, 281, 52, 366, 190, 617, 496, 461, 463, 270, 528, 638, 529, 431, 712, 714, 219, 203, 575, 498, 577, 574, 139, 178, 179, 265, 264, 266, 511, 526, 746, 1082, 426, 36, 242, 300, 301, 795, 32, 241, 49, 51, 50, 250, 145, 774, 785, 474, 475, 452, 789, 552, 157, 818, 460, 459, 352, 46, 39, 311, 312, 277, 455, 608, 878, 220, 221, 321, 533, 699, 877. 6. Model Number/System Code (UDI); Serial Numbers: 722079 (00884838085268); 942, 948, 702, 703465, 1316, 1042, 465, 674, 703413, 1142, 1090, 526, 439, 637, 455, 334, 875, 737, 599, 29, 704281, 801, 671, 1387, 981, 1211, 1213, 499, 1230, 708, 496, 903, 887, 912, 1041, 703324, 528, 703584, 738, 351, 820, 32, 1411, 537, 445, 428, 587, 1290, 251, 1402, 318, 273, 877, 854, 897, 896, 836, 891, 940, 297, 483, 689, 717, 396, 860, 840, 790, 862, 774, 703344, 1436, 629, 1049, 1355, 1414, 703404, 703387, 703317, 703540, 58, 810, 939, 634, 53, 57, 841, 1282, 703310, 1100, 703314, 54, 703408, 246, 890, 703409, 658, 776, 703495, 18, 314, 828, 1323, 645, 646, 325, 731, 262, 1252, 703418, 474, 481, 800, 1359, 1358, 1360, 809, 1258, 1006, 602, 335, 837, 472, 703559, 342, 344, 345, 343, 1232, 1226, 1237, 1236, 34, 1400, 863, 987, 703389, 1391, 1043, 905, 577, 714, 573, 805, 228, 30, 366, 543, 921, 1200, 1222, 353, 703379, 703402, 350, 673, 669, 1212, 1285, 1216, 416, 290, 272, 703306, 35, 43, 40, 1270, 274, 466, 1155, 1033, 703356, 284, 703685, 703550, 703380, 703381, 332, 331, 330, 679, 845, 846, 328, 329, 783, 1016, 1017, 74, 1077, 37, 293, 952, 312, 703351, 703384, 759, 557, 1169, 756, 1306, 703597, 703611, 1129, 234, 75, 316, 740, 1104, 703653, 803, 1388, 67, 1133, 319, 76, 760, 966, 632, 1082, 421, 704131, 704252, 704009, 704215, 1181, 703815, 703330, 782, 1372, 703713, 725, 907, 901, 960, 542, 703470, 1428, 1037, 215, 1035, 703463, 1261, 703321, 831, 832, 410, 224, 495, 340, 839, 728, 339, 282, 444, 1338, 529, 1121, 682, 703560, 727, 576, 630, 703424, 381, 1123, 703385, 71, 583, 703386, 1154, 748, 278, 876, 478, 787, 477, 283, 997, 784, 1116, 703753, 1278, 703313, 703872, 1217, 258, 260, 259, 395, 433, 451, 1405, 703355, 703449, 703654, 703699, 703870, 256, 498, 703638, 703841, 704101, 704171, 1347, 1264, 703834, 704277, 704284, 704150, 703740, 703935, 703995, 703966, 703824, 703961, 1317, 704258, 430, 934, 492, 36, 1202, 833, 834, …
UPC codes
00884838085275, 00884838085282, 00884838085350, 00884838085367, 00884838085251, 00884838085268

Products covered by this recall

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.

Check your product

The notice names 13 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00884838085275
  • 00884838085282
  • 00884838085350
  • 00884838085367
  • 00884838085251
  • 00884838085268

Model or item number

On the rating label, the box or the instruction sheet.

  • 1. Azurion 3 M12

Serial number

On the rating plate, often next to the date of manufacture.

  • 722063
  • 722064
  • 722067
  • 722068
  • 722078
  • 722079

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Philips Medical Systems Nederland B.v. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Veenpluis 4-6, Best

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Philips Medical Systems Nederland B.v. medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00884838085275, 00884838085282, 00884838085350; model number 1. Azurion 3 M12. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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