Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K10...
FDA Device Recall #Z-2623-2025 — Class II — September 3, 2025
Recall Summary
| Recall Number | Z-2623-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 3, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Location | Best, N/A |
| Product Type | Devices |
| Quantity | 1117 units (252 US, 865 OUS) |
Product Description
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Reason for Recall
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Fiji, Finland, France, FrenchPolynesia, Georgia, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Lao, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.
Lot / Code Information
Product Codes: (1)722010, (2) 722026, (3) 722003; UDI-DI: (1) 00884838059030, (2) 00884838054189, (3) N/A; Serial numbers: (1) 764, 177, 662, 905, 480, 499, 833, 787, 1336, 839, 1048, 343, 1011, 917, 108, 671, 677, 468, 1132, 1025, 1226, 411, 1108, 1043, 1302, 160, 1309, 638, 527, 1442, 1109, 679, 467, 986, 1112, 968, 505, 286, 636, 946, 214, 755, 1365, 809, 763, 992, 521, 647, 1176, 67, 1123, 979, 1064, 931, 1209, 1210, 624, 1298, 290, 604, 605, 1126, 422, 1170, 882, 1128, 646, 395, 1233, 1234, 1235, 1236, 690, 698, 306, 478, 1041, 1042, 592, 780, 252, 873, 818, 1230, 1263, 69, 1370, 1369, 999, 728, 280, 488, 1310, 673, 683, 890, 641, 1373, 1040, 308, 360, 1297, 914, 1149, 794, 423, 1118, 878, 920, 1005, 1292, 1144, 453, 364, 792, 1283, 902, 651, 240, 788, 296, 1312, 1391, 1183, 921, 939, 1344, 572, 970, 585, 1181, 1078, 1279, 656, 668, 896, 342, 531, 33, 344, 1308, 1069, 1287, 477, 1261, 241, 298, 285, 694, 414, 714, 785, 601, 654, 1122, 301, 1198, 332, 666, 777, 608, 426, 924, 577, 265, 1047, 219, 959, 901, 552, 935, 1140, 64, 1213, 1015, 1016, 1017, 1018, 1194, 1192, 996, 1188, 1208, 1190, 233, 1211, 418, 1116, 1168, 806, 907, 887, 71, 400, 825, 1339, 1351, 1199, 1137, 713, 948, 1148, 502, 248, 596, 1304, 1197, 602, 1346, 1326, 134, 930, 302, 230, 231, 232, 991, 245, 509, 1093, 1124, 1349, 535, 941, 537, 712, 402, 1034, 1453, 748, 1368, 192, 1331, 447, 1367, 393, 1375, 506, 369, 856, 1191, 802, 706, 1381, 1364, 264, 613, 614, 247, 350, 1206, 490, 1325, 1380, 1165, 1285, 1215, 1256, 424, 1384, 971, 1254, 732, 425, 565, 541, 1360, 699, 759, 657, 658, 642, 696, 1252, 513, 1100, 707, 708, 1220, 734, 735, 736, 737, 469, 1366, 1223, 1353, 1374, 898, 1098, 1113, 1350, 1327, 1361, 1376, 1356, 319, 1163, 1355, 1242, 270, 267, 1091, 940, 578, 1095, 322, 273, 346, 371, 1385, 622, 483, 786, 380, 685, 686, 1086, 46, 1445, 1345, 776, 799, 711, 990, 957, 520, 984, 1225, 771, 1036, 282, 72, 1221, 222, 978, 847, 1151, 340, 653, 1083, 586, 1135, 911, 863, 253, 1180, 398, 49, 740, 625, 936, 631, 1155, 1303, 963, 1232, 496, 287, 299, 945, 915, 885, 297, 1315, 760, 401, 315, 1177, 1178, 811, 600, 692, 382, 828, 816, 769, 1241, 409, 1150, 944, 650, 300, 1111, 1196, 1022, 877, 758, 384, 797, 1276, 1157, 1278, 772, 415, 1216, 1273, 416, 1265, 967, 1452, 1294, 895, 88, 955, 1444, 998, 1012, 860, 494, 960, 1286, 861, 475, 356, 876, 1250, 157, 612, 1007, 1305, 800, 383, 906, 989, 680, 261, 1021, 951, 832, 474, 1266, 406, 1121, 1120, 404, 1053, 428, 579, 503, 493, 211, 217, 351, 528, 559, 1334, 58, 566, 589, 593, 594, 891, 1146, 1267, 328, 518, 568, 904, 700, 701, 810, 850, 842, 744, 1207, 1218, 855, 583, 362, 1313, 1077, 1300, 710, 972, 1076, 934, 1130, 858, 645, 529, 1448, 789, 1067, 1129, 1449, 975, 523, 626, 186, 1617, 223, 555, 598, 702, 1119, 1051, 137, 660, 741, 742, 1029, 1088, 1136, 844, 973, 1000, 394, 1171, 269, 277, 304, 558, 822, 476, 852, 880, 1044, 862, 804, 396, 254, 1182, 276, 320, 997, 1065, 952, 548, 753, 114, 330, 515, 909, 1152, 563, 312, 313, 121, 1193, 1092, 834, 184, 857, 697, 634, 1185, 1055, 782, 1096, 813, 368, 349, 781, 235, 549, 570, 388, 387, 386, 525, 66, 251, 278, 868, 185, 923, 687, 607, 817, 719, 501, 130, 1006, 516, 1147, 1446, 141, 599, 689, (2) 156, 253, 287, 394, 713, 74, 462, 192, 191, 204, 155, 205, 185, 618, 531, 235, 725, 368, 646, 663, 602, 221, 664, 110, 116, 115, 284, 389, 223, 694, 222, 374, 634, 622, 102, 396, 370, 201, 696, 344, 563, 233, 543, 93, 245, 234, 604, 190, 562, 98, 100, 101, 544, 561, 648, 215, 683, 600, 391, 323, 324, 444, 265, 431, 114, 654, 617, 378, 558, 738, 75, 688, 78, 614, 151, 79, 559, 319, 633, 458, 381, 400, 432, 335, 244, 484, 485, 121, 612, 534, 271, 261, 89, 575, 180, 632, 594, 296, 354, 619, 535, 539, 90, 571, 576, 626, 28, 150, 525, 682, 194, 322, 700, 377, 565, 285, 379, 308, 306, 429, 640, 641, 642, 709, 579, 708, 128, 29, 492, 464, 327, 62, 153, 397, 330, 651, 695, 328, 84, 398, 7, 420, 385, 69, 134, 581, 65, 681, 77, 404, 146, 96, 343, 388, 107, 720, 721, 722, 342, 589, 247, 216, 384, 292, 603, 673, 314, 95, 81, 684, 305, 606, 39, 262, 263, 383, 441, 686, 76, 42, 178, 365, 44, 435, 592, 163, 660, 523, 345, 118, 699, 333, 360, 414, 551, 349, 92, 519, 133, 208, 137, 419, 15, 149, 445, 460, 528, 136, 64, 293, 490, 520, 401, 405, 402, 631, 298, 493, 226, 423, 237, 510, 358, 97, 334, 621, 616, 346, 332, 507, 715, 463, 341, 762, 742, 171, 299, 337, 364, 382, 478, 325, 752, 572, 517, 724, 362, 446, 574, 689, 231, 434, 447, 459, 567, 650, 387, 509, 557, 418, 279, 376, 209, 511, 210, 591, 541, 586, 356, 611, 596, 578, 573, 584, 701, 500, 199, 132, 157, 610, 363, 652, 508, 217, 516, 583, 580, 125, 498, 88, 361, 471, 661, 303, 590, 741, 353, 690, 249, 227, 476, 496, 139, 148, 214, 421, 489, 625, 491, 1243, 487, 624, 393, 228, 269, 270, 372, 375, 425, 426, 427, 428, 449, 450, 472, 503, 687, 25, 570, 126, 164, 455, 542, 566, 1201, 532, 547, 706, 206, 466, 442, 443, 105, 38, 70, 106, 655, 669, 83, 160, 486, 198, 495, 469, 268, 568, 835, 40, 252, 477, 301, 188, 189, 1071, 183, 22, 187, 152, 316, 318, 277, 549, 545, 470, 569, 723, 359, 577, 585, 439, 440, 336, 456, 505, 179, 506, 504, 213, 408, 291, 286, 540, 197, 527, 526, 628, 524, 184, 461, 677, 678, 266, 658, 119, 348, 236, 161, 182, 717, 1313, 692, 412, 23, 411, 315, 481, 430, 17, 18, 294, 497, 424, 494, 174, 172, 143, 273, 43, 141, 33, 347, 104, 256, 546, 154, 351, 212, 302, 326, (3) 527, 1349, 1472, 746, 1700, 995, 1529, 92, 1266, 38532, 1001, 1637, 377, CM/0112/138, 763, 599, 1751, 1107, 1388, 2415, 1569, 1570, 1297, 1726, 2521, 1065, 265, 1592, 163, 1396, 1717, 1680, 281, 391, 1273, 1578, 1558, 369, 1176, 492, 1016, 1774, 807, 1325, 1230, 329, 1495, 1414, 205, 162, 321, 1585, 751, 990, 1646, 1784, 136, 1897, 548, 1293, 39, 1H059866, CV402, 1527, 245, 280, 116, 241, 1968, 1014, 1378, 1413, 85400, 863, 192, 1912, 813, 1804, 715, 716, 468, 1452, 948, 288, 1155, 895619, 519, 380, 1669, 388, 1327, 130, 190, 1247, A5E799D03, 1260, 1163, 1518;
Other Recalls from PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2258-2026 | Class II | Azurion system; System Code Description (Model ... | Apr 30, 2026 |
| Z-2259-2026 | Class II | Allura system; System Code Description (Model N... | Apr 30, 2026 |
| Z-2227-2026 | Class II | Azurion system; System Code Description (Model ... | Apr 28, 2026 |
| Z-2229-2026 | Class II | Integris-Allura system; System Code Description... | Apr 28, 2026 |
| Z-2225-2026 | Class II | Philips Azurion systems not configured with an ... | Apr 28, 2026 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.