Z-2503-2025Class II

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

Name: Z-2503-2025 Philips Allura System configured with a 1 Phase UPS. Allura 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 Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper... 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-2503-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-01
Posted: 2025-09-03
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, Model Number 722013 9. Allura Xper FD20 OR Table, Model Number 722023 10. Allura Xper FD10, Model Number 722026 11. Allura Xper FD10/10, Model Number 722027 12. Allura Xper FD20, Model Number 722028 13. Allura Xper FD20/10, Model Number 722029 14. Allura Xper FD20 OR Table, Model Number 722035 15. Allura Xper FD20/20, Model Number 722038 16. Allura Xper FD20/15, Model Number 722058 17. Allura Xper FD20/15 OR Table, Model Number 722059.
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: 1,006 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: 722003 (No UDI); 1225, 789, 1138, 445, 740, 152, 1411. 2. Model Number/System Code (UDI); Serial Numbers: 722005 (No UDI); 35. 3. Model Number/System Code (UDI); Serial Numbers: 722006 (No UDI); 168, 2198, 2184, 2606, 195, 161, 1956, 2256, 2070, 1502, 376, 1096, 1731. 4. Model Number/System Code (UDI); Serial Numbers: 722008 (No UDI); 246, 2470. 5. Model Number/System Code (UDI); Serial Numbers: 722010 (00884838059030); 911, 1180, 936, 338, 660, 411, 992, 1210, 873, 1028, 921. 6. Model Number/System Code (UDI); Serial Numbers: 722011 (00884838059047); 308. 7. Model Number/System Code (UDI); Serial Numbers: 722012 (00884838059054); 525, 823, 1141, 1078, 1811, 2092, 1641, 114, 2134, 1589, 1446, 1675, 1625, 1989, 2156, 455, 233, 2929, 2930, 749, 1080, 149, 854. 8. Model Number/System Code (UDI); Serial Numbers: 722013 (00884838059061); 580, 254, 78, 357, 428. 9. Model Number/System Code (UDI); Serial Numbers: 722023 (00884838059085); 164, 66. 10. Model Number/System Code (UDI); Serial Numbers: 722026 (00884838054189); 287, 825, 462, 192, 74, 191, 204, 155, 967, 1132, 205, 1246, 253, 156, 234, 233, 845, 122, 259, 185, 618, 531, 855, 235, 335, 1068, 843, 805, 646, 965, 258, 220, 602, 908, 221, 664, 109, 110, 116, 117, 115, 284, 389, 223, 694, 222, 436, 1192, 102, 914, 396, 704, 370, 201, 774, 696, 838, 344, 93, 1072, 601, 245, 1340, 604, 627, 190, 605, 935, 297, 98, 99, 100, 101, 544, 1129, 1268, 841, 1239, 1293, 648, 1038, 1231, 215, 683, 142, 1050, 224, 73, 608, 1051, 1052, 323, 324, 931, 265, 431, 654, 786, 617, 87, 990, 1101, 738, 1287, 75, 688, 151, 121, 78, 114, 79, 770, 909, 1000, 612, 319, 458, 381, 826, 716, 432, 244, 534, 807, 962, 986, 961, 638, 830, 759, 1115, 707, 271, 296, 257, 86, 926, 448, 536, 525, 682, 1218, 1273, 1156, 146, 343, 406, 722, 247, 970, 672, 824, 903, 1234, 1065, 673, 603, 888, 790, 758, 314, 304, 606, 263, 262, 457, 1222, 251, 441, 686, 1024, 1086, 992, 178, 1178, 435, 710, 592, 1245, 660, 345, 118, 1219, 333, 338, 360, 730, 551, 349, 727, 519, 133, 195, 196, 137, 528, 460, 529, 530, 126, 455, 542, 566, 978, 1201, 1202, 22, 277, 1317, 545, 723, 359, 846, 506, 197, 628, 1001, 119, 120, 857, 789, 481, 1138, 818, 734, 1137, 154, 313, 502. 11. Model Number/System Code (UDI); Serial Numbers: 722027 (00884838054196); 203, 123, 133, 284, 134, 222, 255, 106, 107, 234, 42, 179, 306, 307, 265, 267, 40, 332, 112, 305, 104, 231, 263, 342, 71, 351, 298, 116, 50, 29, 39, 49, 56, 152, 153, 202, 164, 160, 64, 99, 101, 254, 84, 297, 268, 77, 115, 114, 142, 30, 79, 38, 189, 300, 299, 247, 282, 70. 12. Model Number/System Code (UDI); Serial Numbers: 722028 (00884838054202); 596, 819, 1598, 316, 1946, 541, 565, 647, 674, 864, 710, 946, 949, 880, 1041, 447, 696, 166, 618, 313, 1214, 1846, 1978, 1649, 1256, 904, 242, 284, 1397, 1957, 207, 208, 526, 1677, 1756, 431, 2760, 601, 377, 1454, 1629, 275, 2933, 1340, 539, 356, 236, 237, 238, 422, 525, 350, 560, 1407, 272, 494, 80, 324, 282, 262, 1275, 406, 540, 1017, 840, 842, 136, 137, 793, 1130, 260, 636, 1446, 741, 768, 901, 1657, 1828, 1988, 638, 267, 654, 759, 1656, 1736, 1076, 929, 251, 989, 125, 211, 368, 499, 261, 1424, 1261, 1854, 924, 934, 1142, 1651, 774, 2174, 1463, 2846, 779, 1111, 519, 590, 453, 452, 680, 1074, 318, 11, 1191, 1212, 1211, 1269, 340, 481, 468, 317, 1774, 2502, 982, 339, 128, 655, 143, 1482, 1405, 140, 1448, 1413, 464, 2103, 139, 303, 476, 419, 521, 522, 1132, 580, 861, 1014, 256, 1266, 917, 1472, 2007, 2008, 1652, 1396, 1646, 1394, 254, 326, 1824, 343, 424, 435, 437, 543, 130, 987, 1187, 888, 273, 336, 375, 887, 533, 516, 449, 408, 1549, 376, 744, 1034, 420, 553, 110, 2261, 983, 627, 903, 1099, 1481, 363, 1690, 1233, 2206, 2310, 2506, 1331, 365, 203, 204, 1538, 625, 528, 310, 743, 445, 189, 292, 1466, 1200, 1374, 173, 161, 620, 1085, 361, 281, 475, 456, 1310, 315, 908, 672, 1522, 127, 132, 141, 145, 180, 1001, 463, 1484, 1835, 1244, 1022, 1004, 2173, 210, 1350, 1723, 1834, 2061.2710, 591, 564, 407, 1751, 2284, 697, 364, 520, 2070, 582, 932, 930, 129, 218, 1483, 485, 176, 257, 1920, 962, 1809, 279, 459, 2196, 889, 556, 1149, 1095, 1870, 2253, 347, 909, 1498, 1650, 952, 160, 1569, 966, 306, 234, 213, 1202, 155, 222, 1122, 131, 133, 1855, 224, 490, 1570, 2249, 1869, 1447, 631, 637, 529, 493, 534, 491, 206, 1890, 205, 571, 197, 194, 195, 216, 217, 229, 227, 228, 305, 488, 1822, 1880, 209, 825, 1461, 2709, 2707, 579, 1634, 48, 1783, 498, 462, 1043, 142, 159, 280, 535, 2252, 158, 184, 185, 473, 489, 1826, 466, 671, 978, 402, 1499, 386, 1710, 1708, 1326, 1032, 454, 918, 1705, 914, 698, 1387, 666, 1995, 1889, 1983, 1568, 1980, 1845, 416, 394, 428, 1368, 426, 559, 684, 1333, 547, 550, 190, 973, 1068, 1069, 1630, 346, 1156, 632, 1567, 2407, 2422, 1428, 121, 333, 151, 372, 371, 911, 1633, 717, 1155, 265, 1343, 1439, 1600, 758, 942, 878, 1572, 1039, 763, 231, 663, 822, 1008, 430, 200, 1292, 1046, 728, 1088, 951, 440, 536, 1390, 1645, 827, 1378, 2372, 2373, 503, 2877, 2878, 2720, 853, 415, 1932, 9, 578, 2168, 635, 412, 575, 799, 766, 776, 434, 389, 380, 624, 119, 441, 1937, 105, 111, 687, 2076, 577, 954, 192, 1907, 810, 1128, 899, 1309, 472, 1112, 1307, 1308, 51, 767, 800, 826, 1021, 1235, 1329, 1462, 2314, 1135, 1134, 395, 1210, 2153, 29, 802, 1258, 398, 665, 328, 439, 1632, 322, 2112, 621, 226, 311, 1118, 611, 1120, 1604, 1602, 1601, 1603, 830, 1195, 352, 1268, 1125, 1879, 469, 775, 502, 2274, 113. 13. Model Number/System Code (UDI); Serial Numbers: 722029 (00884838054219); 91, 71, 110, 126, 21, 62, 88, 36, 100, 30, 63, 60, 94, 95, 56, 31, 107, 43. 14. Model Number/System Code (UDI); Serial Numbers: 722035(00884838054240); 85, 24, 101, 117, 21, 38, 177, 121, 183, 88, 57, 125, 119, 100, 165, 47, 52, 131, 124, 169, 46, 74, 30, 60, 59, 196, 216, 187, 34, 222, 72, 111, 128, 1, 96, 53, 160, 104, 191, 70, 154, 142, 134, 129, 65. 15. Model Number/System Code (UDI); Serial Numbers: 722038 (00884838054226); 39, 63, 42, 55, 78, 99, 60, 71, 115, 108, 67, 106, 118, 130, 49, 119, 126, 46, 37, 38, 48, 62, 35, 120, 41, 157, 96, 70, 137, 166, 34, 116, 72, 64. 16. Model Number/System Code (UDI); Serial Numbers: 722058 (00884838059115); 337, 22, 202, 71, 239, 186, 56, 24, 168, 129, 123, 259, 134, 38, 171, 264, 61, 99, 162, 65, 278, 277, 196, 23, 205, 212, 111, 49, 89, 150, 177, 60, 131, 377, 377, 206, 106, 223, 229, 288, 169, 125, 126, 320, 139, 213. 17. Model Number/System Code (UDI); Serial Numbers: 722059 (00884838059122); 7, 8.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2503-2025
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)