Z-2502-2025Class II

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

Name: Z-2502-2025 Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following...
Creator: Philips Medical Systems Nederland B.v.
Published: 2025-08-01
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2025-08-01 / Open, Classified

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of 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... on 2025-08-01. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2502-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-01
Posted: 2025-09-03
Recalling firm: Philips Medical Systems Nederland B.V.
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.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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.
FDA root cause: Under Investigation by firm
Action: Philips notified consignees on about 08/01/2025 via letter. Consignees were informed that systems may still be utilized in accordance with their Instructions for Use (IFU), notify all applicable personnel of this recall, maintain the Urgent Medical Device Correction letter with documentation of the system until Philips corrects the system, and establish an emergency protocol prior to all applicable diagnostics, interventional and minimally invasive procedures to manage the situation should you experience the issue during a procedure. If an affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. Additionally, consignees were requested to complete and return the provided response form and report any issue experienced to Philips.
Quantity in commerce: 1,861 units
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Korea, Republic of, Kosovo, Latvia, Lithuania, Macedonia, Maldives, Malta, Mexico, Moldova, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Panama, Paraguay, Peru, Philippines, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.
Product codes and lots: 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, 1223, 364, 720, 490, 1008, 703845, 1165, 1089, 1330, 743, 271, 791, 370, 1175, 703438, 1150, 72, 844, 786, 1239, 230, 796, 257, 522, 523, 338, 1272, 764. 7. Model Number/System Code (UDI); Serial Numbers: 722221 (00884838099203); 108, 19, 153, 49, 115, 171, 6, 8, 127, 59, 56, 126, 106, 166, 155. 8. Model Number/System Code (UDI); Serial Numbers: 722222 (00884838099210); 55, 23, 44, 45, 187, 223, 99, 100, 101, 332, 51, 65, 11, 268, 188, 77, 80, 245, 109, 83, 50, 244, 177, 280, 13, 300, 5, 9. 9. Model Number/System Code (UDI); Serial Numbers: 722223 (00884838099241); 580, 669, 164, 127, 570, 131, 816, 365, 390, 352, 340, 242, 205, 627, 229, 262, 214, 458, 256, 728, 937, 944, 945, 951, 180, 439, 631, 681, 47, 126, 210, 336, 206, 367, 357, 572, 801, 197, 192, 87, 282, 177, 882, 208, 388, 581, 189, 479, 211, 186, 187, 566, 37, 370, 387, 116, 154, 99, 100, 598, 619, 854, 325, 787, 553, 185, 38, 859, 313, 314, 201, 1083, 860, 382, 645, 647, 646, 648, 30, 296, 297, 41, 914, 461, 808, 165, 33, 559, 563, 564, 558, 114, 176, 321, 661, 913, 246, 245, 422, 2, 639, 91, 333, 1056, 761, 21, 95, 531, 1017, 1037, 392, 358, 618, 590, 65, 295, 840, 12, 68, 465, 547, 702, 34, 450, 376, 451, 792, 876, 1077, 140, 988, 49, 442, 157, 539, 726, 342, 232, 492, 322, 591, 587, 812, 875, 904, 1167, 971, 532, 82, 109, 170, 4, 641, 640, 542, 543, 805, 121, 122, 374, 118, 13, 428, 983, 623, 1009, 515, 660, 712, 305, 179, 1007, 769, 754, 720, 721, 753, 755, 674, 344, 620, 768, 475, 474, 378, 294, 163, 815, 497, 362, 544, 707, 535, 536. 10. Model Number/System Code (UDI); Serial Numbers: 722224 (00884838099258); 606, 1828, 1829, 1830, 1201, 612, 503, 277, 261, 75, 182, 415, 876, 1488, 2957, 266, 512, 1160, 766, 2156, 2138, 250, 226, 360, 790, 452, 1147, 1278, 88, 1142, 792, 595, 892, 814, 813, 2995, 3120, 189, 2139, 2140, 108, 100, 591, 385, 260, 1827, 850, 338, 113, 438, 45, 444, 39, 554, 434, 3207, 696, 1499, 42, 841, 2656, 56, 2331, 421, 589, 2520, 793, 129, 84, 1810, 362, 327, 124, 125, 2280, 239, 1324, 950, 946, 381, 443, 252, 441, 621, 622, 435, 433, 99, 291, 332, 422, 1917, 2248, 2247, 2229, 2246, 1376, 1377, 1514, 351, 1960, 2045, 2403, 80, 183, 366, 101, 564, 396, 120, 454, 300, 1507, 1510, 329, 328, 1336, 307, 953, 1252, 1869, 1458, 904, 940, 1486, 165, 216, 527, 2376, 220, 176, 188, 466, 1112, 2913, 2426, 190, 490, 593, 469, 273, 333, 306, 432, 439, 244, 417, 414, 770, 516, 645, 1409, 565, 1625, 78, 267, 268, 789, 788, 478, 346, 298, 1299, 289, 1873, 2417, 1484, 1335, 1611, 657, 476, 251, 517, 507, 2018, 2239, 1555, 163, 240, 467, 468, 539, 128, 1126, 1246, 1259, 1255, 1256, 900, 191, 64, 1493, 1032, 2222, 1251, 1356, 194, 254, 1403, 440, 246, 2184, 2436, 613, 1565, 229, 286, 1508, 1461, 1512, 1511, 640, 1524, 836, 1692, 141, 574, 109, 2729, 46, 1063, 571, 174, 1490, 2569, 275, 262, 295, 272, 178, 228, 651, 462, 1049, 867, 1954, 1956, 116, 471, 233, 1995, 2185, 2860, 833, 874, 875, 1247, 1478, 330, 649, 173, 172, 379, 1477, 2752, 1672, 35, 1570, 406, 204, 206, 2081, 1042, 1591, 544, 2680, 1298, 513, 2349, 184, 2079, 545, 2080, 2082, 908, 573, 827, 1027, 1026, 1812, 781, 1204, 1184, 221, 208, 633, 3380, 816, 732, 647, 2510, 1388, 145, 2534, 2527, 2124, 1325, 2638, 632, 1766, 2214, 2269, 2575, 1169, 2515, 2337, 2338, 2823, 2825, 1539, 463, 368, 2415, 383, 563, 519, 1686, 2089, 2574, 1367, 988, 2163, 2725, 2724, 93, 1671, 1594, 1595, 2568, 1401, 2851, 1092, 534, 86, 1572, 634, 782, 1406, 3223, 19, 2230, 2480, 1962, 2218, 227, 337, 822, 1981, 1953, 1864, 749, 1952, 382, 4, 37, 1778, 3135, 648, 971, 2983, 861, 2482, 31, 1523, 59, 898, 866, 2730, 52, 29, 853, 810, 1722, 724, 1431, 171, 413, 2310, 2804, 596, 1737, 801, 937, 1326, 1330, 1349, 1350, 1369, 1609, 2244, 2245, 2373, 3099, 731, 1505, 1552, 280, 764, 1065, 910, 142, 1421, 721, 1430, 2068, 654, 397, 557, 1188, 2134, 2424, 1814, 2101, 2103, 2618, 2343, 2260, 2259, 2261, 2267, 2706, 2707, 2714, 2758, 2813, 3288, 2812, 2828, 1800, 1799, 2263, 2300, 2299, 2705, 2745, 2704, 2819, 2905, 2788, 2817, 2889, 3287, 3286, 3295, 1815, 2102, 2105, 2749, 2751, 1930, 2715, 1139, 156, 1562, 803, 671, 1538, 1730, 387, 13, 399, 2151, 424, 16, 2007, 3, 1331, 7, 863, 8, 358, 3259, 658, 1051, 1050, 1052, 1053, 1054, 1080, 1348, 2277, 604, 3271, 542, 729, 203, 1728, 1736, 610, 2344, 48, 635, 2848, 1272, 2402, 799, 800, 85, 2050, 537, 1566, 1588, 1656, 1649, 1447, 2046, 1602, 2013, 18, 1536, 1580, 1387, 1433, 1957, 1678, 2011, 2076, 2099, 1703, 1933, 1837, 2275, 1196, 1391, 1393, 1404, 1402, 2916, 1645, 1854, 1359, 1443, 1587, 1392, 1399, 1422, 1677, 1691, 1710, 2009, 1345, 2014, 1600, 1620, 2028, 2071, 1425, 1340, 1333, 1855, 2153, 1585, 1372, 1408, 1432, 2049, 1586, 2055, 1429, 1535, 1537, 1544, 1543, 1865, 1597, 1398, 1462, 1596, 1603, 1598, 1327, 2056, 2175, 2330, 1968, 1936, 1351, 2016, 1980, 1495, 2002, 2087, 1666, 1584, 2069, 2398, 1806, 1969, 1601, 1621, 1589, 1699, 1734, 1758, 2305, 2339, 1835, 1583, 1868, 1805, 1644, 2021, 2104, 727, 2057, 213, 509, 1932, 2621, 3263, 984, 344, 829, 1590, 2017, 1522. 11. Model Number/System Code (UDI); Serial Numbers: 722225 (00884838099265); 259, 55, 268, 147, 340, 72, 71, 216, 299, 291, 289, 249, 110, 298, 46, 29, 122, 233, 157, 149, 237, 167, 364, 4, 398, 30, 231, 38, 219, 170, 171, 90, 89, 77, 369, 161, 163, 137, 162, 40, 91, 74, 125, 190, 303, 377, 211, 329, 280, 86, 8, 31, 384, 87, 283, 421, 422, 267, 241. 12.Model Number/System Code (UDI); Serial Numbers: 722226 (00884838099272); 219, 120, 272, 105, 144, 319, 204, 255, 153, 350, 442, 183, 78, 467, 108, 143, 360, 555, 114, 209, 174, 687, 281, 554, 181, 147, 379, 468, 173, 271, 182, 419, 472, 122, 123, 124, 125, 126, 127, 403, 294, 194, 249, 432, 892, 87, 790, 261, 514, 766, 941, 228, 539, 950, 489, 622, 628, 637, 491, 345, 625, 93, 238, 299, 166, 364, 5, 506, 557, 227, 188, 827, 453, 883, 171, 708, 738, 655, 382, 106, 56, 196, 236, 770, 73, 302, 402, 210, 304, 916, 904, 40, 525, 653, 157, 657, 583, 540, 216, 456, 357, 596, 733, 439, 118, 263, 24, 840, 88, 224, 231, 233, 407, 598, 21, 762, 882, 505, 542, 507, 497, 485, 490, 494, 643, 644, 543, 636, 849, 633, 634, 504, 550, 551, 484, 631, 316, 639, 640, 642, 563, 547, 591, 911, 277, 278, 207, 773, 832, 501, 1000, 810. 13. Model Number/System Code (UDI); Serial Numbers: 722227 (00884838099227); 88, 135, 261, 19, 133, 134, 241, 164, 82, 32, 16, 12, 72, 64, 242, 176, 2, 75, 145, 143, 120, 112, 74, 188, 147, 146, 77, 141, 234, 14, 15, 47, 95, 163, 48, 3, 1, 123, 92, 173, 174, 121, 204, 57, 282, 8, 9. 14. Model Number/System Code (UDI); Serial Numbers: 722228 (00884838099234); 187, 328, 113, 205, 204, 150, 159, 23, 127, 24, 10, 36, 6, 213, 64, 20, 26, 47, 149, 62, 502, 18, 125, 391, 395, 229, 12, 408, 309, 310, 557, 98, 261, 179, 536, 143, 46, 70, 7, 13, 191, 259, 218, 11, 223, 370, 389, 14, 71, 39, 465, 552. 15. Model Number/System Code (UDI); Serial Numbers: 722282 ((01)00884838110571(21)8); 8.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2502-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2502-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03
Z-2503-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-03

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)