Recall Weekly
Moderate riskFDA DeviceClass II

Philips ALLURA Xper FD10 X-ray system recalled for intermittent foot switch failure

Philips has identified a defect in the wired foot switch on certain ALLURA Xper FD10 X-ray imaging systems that may prevent X-ray imaging from starting or cause it to work intermittently. This could delay or disrupt imaging procedures. Philips is working with healthcare facilities to resolve the issue.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. If you operate or maintain an ALLURA Xper FD10 system, check your serial number against the affected units list
  2. Contact Philips Medical Systems for instructions on repair or replacement of the foot switch
  3. Do not rely solely on the wired foot switch until the issue is resolved; use alternative imaging initiation methods if available
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 22 products — see all of them.

Details

Units affected
2291 units (493 US, 1798 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 6, Best, Netherlands
Classification
Class II
Recall number
Z-1661-2026

In the FDA's words

Description
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. (1) System Code: 722003; UDI: N/A; System Serial Number: 445, 1555, 1084, 1411, 1232, 1259, 1023, 1947, 392, 1133, 1135, 1627, 746, 98, 1078, 367, 1584, 1599, 1153, 1154, 1032, 1694, 259, 1471, 1474, 684, 657, 385, 1551, 947, 1360, 1482, 1489, 177, 1634, 1663, 1704, 1214, 546, 1089, 305, 2936, 92, 1092, 1869, 119, 928, 1449, 1805, 998, 501, 503, 1114, 345, 1443, 1444, 8198, 63, 1189, 1954, 1575, 1728, 1430, 147, 1326, 700, 1446, 401, 1615, 939, 527, 1067, 1787, 1529, 104, 342, 390, 1353, 159, 160, 472, 197, 1349, 1271, 653, 917, 997616, 1072, 1594, 574, 892, 1138, 1001, 1950, 447, 1043, 994, 995, 1514, 1525, 1311, 8091, 1472, 1621, 1622, 72, 1187, 1222, 1948, 963, 1700, 1343, 619915, 1667, 463, 959, 1031, 912, 913, 1647, 521, 590, 591, 855, 328A, 696, 1807, 690, 1714, 37, 1799, 1286, 257, 1188, 940, 1512, 1891, 1223, 640, 103, 24, 406, 467, 285, 1637, 453, 833, 1738, 1749, 430, 1491, 1605, 1130, 5, 674, 639, 797, 1033, 1357, 1632, 1631, 391, 281, 1535, 1038, 1045, 1536, 350, 452, 629, 732, 754, 1056, 810, 1610, 1611, 1804, 1122, 1413, 644, 1059, 513, 1163, 1193, 1549, 418, 1778, 1199, 2933, 517, 1597, 1585, 1063, 1596, 337, 1746, 1747, 1619, 288, 988, 535, 1717, 1641, 1395, 411, 412, 413, 414, 415, 1338, 319, 1706, 1572, 1916, 1282, 789, 614, 763, 728, 605, 622, 492, 1612, 1648, 1613, 1568, 1569, 1685, 948, 505, 566, 1297, 895619, 1277, 321, 239, 1216, 328, 329, 190, 1586, 1492, 863, 1616, 359, 1169, 1118, 230, 1421, 1416, 1260, 1609, 115, 1337, 519, 370, 1155, 13, 162, 1478, 1090, 1662, 1818, 1730, 1463, 1752, 1215, 1558, 1578, 1083, 1014, 1378, 985, 1231, 356, 307, 308, 309, 310, 777, 778, 780, 1127, 1167, 1186, 1638, 898, 82, 136, 1646, 1689, 715, 423, 1571, 1101, 1399, 1931, 1149, 753, 1255, 424, 1733, 606, 1247, 751, 1293, 548, 813, 1524, 1457, 1906, 1979, 249, 1509, 937, 1016, 116, 1857, 676, 875, 373, 1774, 1923, 313, 314, 1161, 1919, 1723, 374, 1328, 1664, 750, 1396, 1582, 1445, 1511, 1576, 1680, 1104, 560, 1735, 4516100000005820, 1064, 1458, 949, 1592, 1708, 1709, 265, 1119, 1176, 369, 1230, 1925, 1246, 1755, 1756, 339, 861, 1606, 1649, 1823, 1325, 1633, 596, 1527, 1784, 1834, 464, 1456, 796, 1273, 1110, 1751, 1928, 468, 839, 1025, 272, 1593, 1743, 538, 1684, 1198, 292, 1669, 1630, 1697, 1022, 770, 708, 1, 744, 1125, 1661, 344, 1760, 1567, 1495, 782, 1132, 1483, 1452, 1603, 1207, 1409, 1412, 1500, 1501, 39, 1748, 1414, 1692, 1595, 1203, 1764, 245, 1058, 1027, 346, 961, 1172, 255, 1469, 1112, 1278, 354, 416, 363, 582, 1518, 1666, 1352, 205, 899, 883, 161, 1280, 569, 922, 547, 1691, 1329, 241, 667, 578; (2) System Code: 722010; UDI: 00884838059030; System Serial Number: 1123, 932, 239, 42, 360, 209, 500, 794, 921, 939, 286, 1440, 160, 1144, 521, 33, 107, 1025, 656, 668, 1261, 1170, 585, 364, 1128, 882, 499, 1230, 280, 488, 787, 968, 890, 780, 190, 1181, 694, 1279, 344, 1149, 423, 1176, 1173, 1040, 67, 1309, 763, 931, 306, 478, 240, 1298, 970, 1226, 290, 365, 651, 1275, 1292, 755, 671, 677, 1336, 477, 1078, 467, 65, 1369, 792, 679, 485, 395, 592, 1312, 1302, 505, 229, 414, 714, 785, 647, 1283, 119, 662, 1233, 1234, 1235, 1236, 690, 698, 158, 1009, 992, 1214, 1064, 979, 764, 920, 788, 1396, 902, 1344, 1183, 453, 296, 1118, 411, 1209, 1210, 1041, 1042, 1432, 308, 833, 1310, 728, 791, 480, 1263, 986, 987, 422, 905, 218, 1005, 1425, 1397, 1398, 1132, 468, 127, 1442, 1048, 646, 648, 1126, 252, 873, 1011, 343, 1370, 69, 1391, 838, 999, 175, 285, 636, 624, 241, 1084, 896, 673, 683, 1441, 914, 342, 531, 818, 1395, 637, 917, 214, 1043, 1365, 1109, 1297, 572, 1436, 638, 1112, 1373, 946, 878, 1108, 809, 830, 839, 1069, 1287, 1308, 169, 1424, 604, 605, 777, 666, 1122, 654, 301, 601, 426, 924, 265, 1198, 577, 332, 1047, 1187, 447, 1250, 1147, 1034, 1421, 1258, 193, 652, 1015, 1016, 1017, 1018, 1423, 1332, 1106, 980, 1169, 1438, 322, 251, 278, 868, 383, 782, 125, 52, 697, 523, 707, 708, 1146, 1267, 566, 594, 891, 861, 1321, 1096, 906, 1366, 374, 1363, 243, 524, 382, 1428, 225, 812, 813, 857, 409, 733, 555, 598, 844, 95, 1285, 212, 396, 139, 1055, 1202, 928, 1185, 368, 1374, 772, 410, 58, 786, 126, 1050, 37, 1361, 1153, 1166, 915, 951, 197, 494, 884, 273, 544, 146, 299, 121, 62, 1113, 802, 803, 769, 540, 1385, 192, 1278, 529, 1007, 1305, 1306, 612, 1077, 1093, 1203, 1216, 620, 300, 1058, 1334, 351, 528, 559, 1006, 141, 740, 828, 1192, 715, 635, 520, 570, 384, 90, 811, 53, 901, 223, 1095, 552, 1326, 973, 596, 45, 712, 1148, 1349, 323, 825, 402, 713, 312, 195, 900, 277, 176, 806, 907, 967, 795, 1272, 816, 1154, 1439, 1404, 1431, 63, 346, 157, 1427, 692, 270, 600, 655, 610, 762, 888, 936, 50, 990, 665, 315, 1444, 1003, 1617, 220, 1200, 1152, 819, 613, 614, 634, 136, 944, 255, 817, 1140, 793, 393, 518, 568, 563, 330, 367, 473, 515, 1315, 415, 952, 866, 1002, 1429, 1430, 418, 778, 954, 781, 720, 911, 354, 186, 719, 978,
Hazard
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

22 products in this recall

Philips X-ray systems recalled for faulty foot switch

Philips is recalling 22 models of its Allura Xper and Azurion X-ray imaging systems. The recall covers a wired foot switch that may fail to start X-ray imaging or may start it intermittently. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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