Recall archive / FDA device enforcement
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allu... — FDA record Z-0676-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 11, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.
- Reason
- Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.
- Classification
- Class II
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Quantity
- 2,782 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0676-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1. Model Number: 722010. UDI (Serial Numbers): (01)00884838054189(21)164 (164); (01)00884838059030(21)272 (272); (01)00884838059030(21)819 (819); (01)00884838059030(21)828 (828); No UDI (33, 39, 42, 43, 65, 67, 69, 79, 107, 119, 127, 158, 160, 169, 177, 190, 191, 209, 213, 214, 215, 218, 227, 229, 239, 240, 241, 252, 274, 280, 285, 286, 290, 296, 298, 306, 308, 316, 342, 343, 344, 360, 364, 365, 395, 411, 414, 422, 423, 453, 468, 477, 478, 480, 485, 488, 499, 500, 505, 521, 527, 531, 567, 572, 585, 592, 604, 605, 611, 624, 636, 637, 638, 641, 646, 648, 651, 656, 662, 668, 670, 671, 673, 677, 679, 683, 690, 694, 698, 714, 728, 730, 755, 763, 764, 780, 785, 787, 788, 791, 792, 794, 809, 818, 830, 833, 838, 839, 873, 878, 882, 890, 896, 902, 905, 914, 917, 920, 921, 931, 932, 937, 939, 946, 968, 970, 979, 986, 987, 992, 999, 1005, 1009, 1011, 1025, 1028, 1040, 1041, 1042, 1043, 1048, 1064, 1069, 1078, 1082, 1084, 1109, 1112, 1118, 1123, 1126, 1128, 1132, 1144, 1170, 1173, 1176, 1181, 1183, 1209, 1210, 1214, 1230, 1233, 1234, 1235, 1236, 1261, 1263, 1275, 1279, 1283, 1292, 1297, 1442, 601, 654, 1122, 1198, 332, 777, 666, 301, 608, 1081, 426, 924, 577, 265, 1047, 1187, 219, 959, 901, 552, 888, 1140, 64, 935, 1008, 1213, 1015, 1016, 1017, 1018, 374, 524, 1153, 1192, 1194, 841, 964, 996, 233, 1211, 721, 1190, 1188, 806, 907, 50, 418, 71, 400, 1168, 1116, 1093, 53, 370, 596, 45, 712, 1148, 323, 825, 402, 713, 195, 176, 508, 123, 1197, 91, 602, 245, 535, 230, 231, 232, 991, 248, 92, 187, 502, 1124, 537, 1199, 941, 553, 302, 289, 173, 134, 1137, 948, 509, 619, 1034, 447, 707, 708, 1285, 928, 1113, 802, 803, 192, 613, 614, 393, 506, 369, 1206, 264, 699, 759, 722, 1100, 350, 748, 1220, 657, 658, 659, 854, 565, 734, 735, 736, 737, 228, 642, 1054, 490, 391, 425, 513, 898, 424, 105, 993, 732, 580, 1256, 704, 695, 696, 238, 706, 1253, 1327, 1032, 319, 1252, 469, 541, 731, 1019, 1023, 1215, 247, 1191, 856, 51, 971, 603, 1003, 270, 267, 268, 1242, 47, 1089, 831, 530, 1091, 193, 578, 322, 1161, 126, 197, 884, 146, 62, 1095, 273, 29, 63, 412, 346, 622, 371, 740, 715, 635, 1134, 1135, 520, 936, 990, 1002, 911, 49, 978, 586, 1004, 1036, 653, 1086, 1180, 776, 288, 1245, 72, 625, 1221, 1087, 984, 253, 398, 1125, 1269, 773, 80, 380, 224, 222, 1010, 957, 282, 847, 1151, 1083, 1268, 711, 685, 686, 1104, 663, 664, 863, 799, 1224, 1225, 771, 631, 494, 1250, 652, 1106, 383, 52, 1278, 861, 906, 872, 382, 409, 969, 139, 1202, 28, 410, 1050, 915, 544, 299, 769, 540, 1007, 1305, 1306, 612, 1203, 1216, 620, 300, 1058, 600, 384, 90, 811, 1138, 967, 795, 1154, 655, 610, 895, 136, 944, 255, 415, 866, 954, 720, 83, 1141, 86, 88, 246, 801, 498, 1039, 574, 495, 1265, 1177, 1178, 128, 1105, 1266, 97, 703, 526, 1237, 650, 98, 427, 496, 1286, 897, 649, 401, 963, 876, 275, 800, 1012, 102, 1238, 475, 1090, 261, 739, 356, 877, 34, 35, 249, 1196, 1276, 1294, 927, 375, 162, 333, 943, 293, 903, 1111, 797, 416, 955, 1145, 514, 100, 1273, 1157, 860, 942, 961, 287, 1021, 1033, 998, 733, 154, 353, 1150, 832, 474, 471, 962, 1037, 1053, 579, 211, 404, 428, 503, 493, 1120, 837, 406, 351, 528, 559, 217, 529, 58, 566, 588, 589, 590, 591, 593, 594, 891, 949, 1146, 1267, 518, 568, 842, 744, 106, 103, 104, 385, 956, 70, 850, 250, 1097, 904, 75, 199, 328, 182, 294, 77, 751, 810, 1280, 1300, 1077, 858, 362, 1207, 874, 131, 1218, 1130, 972, 710, 934, 587, 645, 855, 178, 790, 466, 94, 276, 952, 548, 115, 997, 116, 753, 606, 320, 114, 181, 1182, 1065, 562, 180, 789, 1067, 1129, 975, 626, 89, 523, 243, 223, 1617, 186, 555, 598, 1119, 702, 321, 338, 137, 1051, 660, 1088, 741, 742, 1029, 1136, 95, 844, 973, 1162, 1000, 394, 142, 561, 277, 269, 304, 558, 132, 804, 1044, 822, 852, 476, 862, 96, 396, 254, 373, 875, 312, 313, 900, 220, 563, 330, 367, 473, 515, 909, 112, 121, 762, 564, 1074, 1075, 20, 124, 357, 807, 834, 1066, 184, 697, 857, 634, 980, 782, 783, 125, 1096, 225, 812, 813, 1055, 913, 1185, 368, 349, 570, 781, 354, 386, 387, 525, 66, 388, 235, 236, 549, 251, 278, 868, 1006, 1060, 516, 517, 774, 60, 166, 501, 845, 846, 597, 381, 492, 908, 607, 507, 923, 775, 403, 719, 687, 78, 1030, 1031, 185, 1147, 689). 2. Model Number: 722011. No UDI. Serial Numbers: 157, 83, 308, 95, 107, 34, 59, 23, 319, 49, 170, 137, 173, 101, 84, 155, 133, 234, 345, 124, 332, 102, 270, 177, 132, 325, 15, 76, 79, 17, 87, 237, 255, 50, 171, 168, 22, 275, 344, 324, 140, 163, 172, 103, 82, 154, 215, 40, 69, 272, 286, 81, 224, 184, 266, 175, 146, 164, 334, 338, 165, 80, 231, 323, 327, 179, 145, 117, 6, 355, 151, 202, 21, 203, 214, 340, 18, 301, 302, 303, 304, 305, 306, 307, 257, 265, 127, 180, 259, 181, 211, 206, 217, 314, 98, 201, 341, 318, 347, 261, 178, 183, 271, 253, 230, 317, 198, 321, 204, 94, 104, 52, 290, 291, 244, 333, 287, 39, 282, 78, 216, 158, 329, 246, 295, 56, 337, 292, 125, 225, 300, 88, 309, 86, 222, 71, 156, 233, 31, 188, 77, 99, 238, 223, 51, 153, 68, 129, 186, 118, 119, 41, 55, 263, 278, 258, 32, 89, 108, 310, 311, 139, 141, 66, 274, 296, 243, 191, 227, 273, 161, 220, 242, 166, 189, 185, 100, 190, 299, 280, 199, 194, 74, 75, 228, 250, 251, 91, 213, 12, 212, 113, 152, 112, 111, 115, 114, 116, 43, 277, 313, 26, 27, 29. 3. Model Number: 722012. UDI (Serial Numbers): (01)00884838059054(21)1356 (1356); (01)00884838059054(21)191 (191); (01)00884838059054(21)351 (351); (01)00884838059054(21)583 (583); (01)00884838059054(21)655 (655); (01)00884838059054(21)796 (796); (01)00884838059054(21)950 (950); No UDI (1117, 1001, 1673, 1712, 585, 517, 1545, 70, 1715, 504, 757, 935, 1250, 1613, 2006, 1733, 1734, 2201, 1922, 741, 92, 1034, 1359, 1848, 865, 1908, 1166, 1113, 1659, 494, 335, 1804, 1473, 1408, 1401, 1588, 576, 595, 590, 2302, 1279, 2151, 481, 348, 543, 893, 1187, 1455, 2085, 2202, 423, 525, 1798, 1656, 399, 990, 1871, 951, 1652, 894, 1590, 1597, 596, 1054, 1189, 1099, 823, 1037, 566, 72, 448, 1606, 924, 1610, 686, 1108, 1294, 568, 500, 459, 469, 1422, 1077, 1537, 1035, 285, 243, 84, 1317, 1649, 1895, 1900, 1723, 878, 919, 1581, 2221, 2222, 1515, 1803, 1731, 1017, 1020, 380, 1811, 2171, 1497, 782, 418, 1053, 1558, 1336, 601, 1014, 684, 1265, 331, 389, 732, 751, 1324, 2276, 2086, 1285, 2219, 298, 814, 815, 1120, 278, 297, 1713, 1506, 580, 1098, 1852, 1307, 1858, 377, 758, 1598, 172, 2054, 856, 1690, 1407, 480, 690, 579, 1327, 733, 1091, 1254, 797, 213, 735, 1280, 2138, 828, 458, 1118, 740, 1249, 542, 1033, 2265, 490, 1075, 2203, 1321, 1396, 605, 606, 444, 66, 2092, 1269, 67, 244, 1002, 1022, 1023, 2264, 2234, 1805, 1192, 1823, 483, 484, 615, 2150, 892, 1478, 1262, 1688, 1961, 1732, 1062, 649, 650, 767, 1104, 1641, 1277, 1975, 276, 316, 1335, 1461, 159, 489, 766, 639, 669, 671, 1583, 451, 625, 651, 1047, 107, 1447, 99, 670, 124, 1616, 1660, 1083, 1807, 1924, 511, 1714, 122, 101, 75, 1406, 352, 492, 472, 1105, 642, 643, 1270, 577, 578, 1306, 855, 1456, 2269, 71, 1078, 2285, 1793, 1797, 1216, 948, 387, 498, 1662, 104, 1868, 1743, 369, 1239, 1561, 464, 2293, 1960, 616, 1508, 1084, 1038, 1058, 318, 1990, 1796, 1026, 1337, 685, 656, 1560, 1441, 2926, 1854, 2288, 473, 2068, 624, 1586, 1617, 1904, 1354, 1918, 1906, 160, 383, 560, 68, 114, 1948, 1195, 518, 888, 1329, 1992, 323, 379, 792, 1003, 1219, 89, 115, 2003, 2004, 135, 1832, 2133, 2166, 562, 1941, 760, 859, 1593, 1608, 1947, 1950, 731, 520, 1328, 848, 2292, 1946, 274, 1063, 611, 1587, 1226, 613, 1271, 1842, 205, 2147, 1799, 1665, 187, 1513, 2015, 2207, 319, 2161, 1116, 1993, 208, 943, 150, 1281, 1945, 1919, 110, 337, 1735, 1326, 788, 488, 2002, 132, 1218, 1519, 1533, 336, 694, 1334, 2013, 1405, 1141, 923, 925, 533, 406, 1293, 513, 1446, 1625, 1675, 1683, 1148, 1181, 207, 1305, 790, 499, 1716, 934, 1726, 85, 476, 1657, 1045, 1531, 1630, 851, 1827, 277, 1923, 1516, 404, 453, 321, 334, 197, 1869, 2215, 574, 1611, 1559, 2924, 1686, 1635, 858, 1224, 1345, 86, 2057, 1430, 1255, 1599, 302, 610, 1209, 920, 666, 1989, 2014, 2022, 1126, 1943, 1188, 1073, 1404, 1664, 103, 1272, 2063, 1467, 1596, 326, 926, 675, 756, 1027, 424, 1894, 2145, 2146, 2148, 2065, 1527, 1477, 2227, 1177, 1645, 93, 95, 1167, 1595, 88, 1672, 909, 1210, 1512, 1101, 787, 1399, 123, 126, 136, 952, 953, 954, 1005, 1661, 2156, 320, 186, 455, 570, 1622, 1115, 1316, 1212, 975, 976, 1032, 1746, 986, 971, 1594, 233, 239, 640, 446, 69, 430, 1542, 76, 1607, 1211, 1004, 2046, 974, 1044, 505, 310, 192, 314, 852, 224, 1016, 1097, 315, 1532, 1964, 2135, 1357, 589, 1092, 248, 846, 963, 964, 1658, 1344, 1902, 328, 781, 1909, 1132, 1361, 1504, 1433, 229, 142, 962, 1260, 1094, 837, 333, 1681, 1815, 922, 1333, 774, 1492, 2047, 1655, 1855, 2098, 930, 1052, 1421, 627, 1428, 1994, 1802, 1956, 931, 1817, 309, 2168, 1168, 1562, 967, 167, 910, 632, 863, 957, 289, 137, 1040, 1444, 409, 993, 995, 57, 1072, 516, 2042, 1332, 809, 795, 1460, 170, 914, 1156, 347, 1291, 1971, 664, 180, 1376, 2107, 139, 350, 628, 1865, 550, 1872, 759, 1464, 1363, 1457, 2020, 553, 288, 1980, 1580, 1708, 1495, 1244, 556, 546, 806, 1289, 1284, 1144, 1145, 223, 1081, 1436, 726, 755, 648, 1391, 1972, 215, 871, 629, 1631, 125, 432, 966, 1157, 1623, 1702, 916, 2112, 2123, 2118, 98, 1297, 2103, 211, 1147, 1303, 2300, 2120, 199, 1833, 1874, 631, 1887, 891, 1382, 1471, 1818, 2270, 1878, 1462, 1384, 798, 165, 210, 1203, 1966, 1178, 1999, 793, 794, 667, 2196, 1669, 502, 1021, 1142, 1879, 1703, 2031, 659, 1572, 1076, 2291, 1093, 479, 1043, 1626, 2056, 608, 1624, 216, 2204, 1138, 839, 805, 381, 752, 555, 1548, 1814, 1808, 979, 390, 261, 269, 2188, 1056, 866, 1699, 619, 1267, 311, 477, 1174, 1485, 59, 541, 1415, 764, 388, 876, 1150, 1701, 1693, 2080, 1986, 772, 1241, 1819, 1898, 911, 978, 2093, 116, 56, 2181, 599, 2034, 1071, 622, 941, 1088, 1927, 1412, 181, 548, 582, 588, 1567, 1367, 1143, 1423, 1268, 279, 1592, 1122, 2028, 1375, 1059, 400, 166, 746, 771, 770, 2177, 280, 1202, 753, 2274, 2198, 1028, 581, 1309, 810, 1086, 524, 1390, 1721, 374, 738, 360, 992, 219, 1825, 1839, 652, 2102, 2127, 1834, 829, 1434, 665, 742, 737, 1360, 1349, 391, 415, 2095, 730, 1967, 1996, 763, 332, 867, 902, 917, 1366, 2096, 1201, 587, 1061, 2072, 1691, 1861, 407, 1741, 833, 554, 214, 779, 799, 2101, 1228, 2117, 534, 1348, 813, 1740, 1530, 998, 1266, 680, 1997, 441, 60, 803, 2195, 895, 509, 1736, 355, 1381, 112, 478, 227, 785, 291, 185, 1450, 540, 1976, 2016, 1591, 443, 106, 127, 382, 661, 727, 1137, 1795, 1128, 1377, 392, 1134, 1130, 296, 266, 1074, 376, 2067, 152, 1978, 663, 1678, 569, 1481, 2349, 436, 1929, 1654, 287, 944, 2176, 1413, 188, 2140, 1998, 635, 1089, 1668, 1256, 2272, 660, 1671, 743, 58, 128, 1287, 1079, 61, 982, 693, 1388, 184, 1479, 1801, 2074, 1342, 405, 1535, 1882, 1127, 980, 2058, 1705, 260, 539, 2278, 748, 1435, 528, 506, 1885, 1926, 2073, 572, 688, 903, 410, 901, 869, 728, 91, 218, 419, 275, 830, 2094, 1411, 1222, 1397, 272, 2153, 1711, 1965, 1480, 1937, 1298, 414, 338, 1237, 1151, 1152, 1347, 1977, 1836, 1131, 1242, 573, 1484, 117, 2082, 1695, 817, 1536, 630, 593, 773, 1214, 936, 679, 1816, 544, 2392, 1862, 1364, 2033, 1296, 2200, 2017, 2208, 1175, 1233, 1653, 1463, 955, 2087, 1698, 1064, 1958, 271, 1135, 1385, 870, 507, 2182, 1223, 1288, 2008, 398, 1234, 965, 662, 868, 1483, 1489, 647, 1232, 2175, 1984, 222, 840, 175, 176, 1261, 437, 557, 1082, 1633, 426, 672, 1379, 872, 1973, 1822, 144, 692, 1820, 1821, 1312, 2077, 161, 140, 1696, 678, 780, 73, 74, 1292, 1466, 34, 119, 2043, 155, 1837, 118, 1451, 598, 1158, 1153, 1663, 1546, 835, 177, 1720, 749, 1400, 1897, 1246, 1245, 1939, 897, 2137, 111, 2206, 1585, 880, 1845, 777, 403, 26, 523, 1951, 2144, 1494, 2921, 385, 1930, 609, 1748, 1425, 1988, 2000, 148, 592, 1870, 674, 1049, 510, 2294, 2316, 1829, 1838, 1915, 1172, 687, 1710, 80, 1987, 428, 602, 623, 2220, 775, 988, 1582, 1979, 928, 807, 1322, 529, 1891, 465, 1719, 808, 1048, 1024, 824, 745, 617, 985, 1259, 1136, 2927, 1534, 1350, 1452, 1620, 802, 913, 1180, 354, 1813, 522, 983, 1121, 421, 1867, 1198, 416, 1840, 1812, 2066, 212, 933, 1676, 1634, 2059, 1541, 1338, 1520, 1955, 178, 249, 1418, 1251, 1176, 1417, 1899, 1454, 1055, 1962, 1015, 1124, 1547, 2266, 1230, 1543, 1609, 1744, 2110, 1553, 2922, 940, 1639,... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide distribution. International distribution to Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 18, 2024
- Recall initiation date
- Nov 11, 2024
- Center classification date
- Dec 12, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.