Z-2623-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 1, 2025
- Initiation Date
- September 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
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;