PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722

Hazard / Issue

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: (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, 46, 831, 1067, 1129, 789, 940, 83, 123, 586, 1193, 501, 166, 758, 64, 1056, 1004, 1403, 1141, 86, 111, 1241, 1171, 909, 548, 1371, 1393, 267, 1036, 597, 653, 1086, 88, 1180, 381, 776, 115, 219, 959, 349, 533, 386, 801, 498, 1402, 1053, 997, 116, 579, 211, 404, 428, 503, 493, 1120, 1121, 406, 753, 606, 226, 387, 1452, 495, 1244, 945, 1088, 1245, 996, 137, 297, 1265, 72, 1177, 1178, 128, 525, 625, 1221, 607, 744, 700, 701, 400, 71, 20, 1434, 1392, 984, 1105, 1266, 615, 130, 923, 1208, 1051, 1206, 975, 1168, 253, 398, 1211, 233, 320, 1039, 97, 703, 526, 1237, 650, 98, 427, 496, 1286, 680, 1232, 649, 401, 1194, 774, 963, 876, 275, 660, 885, 800, 264, 228, 699, 1356, 475, 1331, 369, 759, 722, 1384, 1352, 350, 1357, 1098, 1099, 748, 1220, 657, 658, 659, 854, 1325, 565, 506, 734, 735, 736, 737, 642, 1255, 1360, 1054, 391, 425, 513, 1381, 1163, 1164, 1342, 898, 1364, 424, 1368, 105, 993, 732, 1256, 580, 704, 261, 695, 696, 1367, 1353, 1378, 1379, 238, 1389, 1254, 1390, 1394, 706, 1253, 1327, 1165, 1032, 319, 1223, 1252, 739, 1380, 1019, 1023, 541, 731, 1215, 247, 1191, 856, 1375, 1350, 971, 1345, 356, 877, 164, 1125, 960, 272, 1426, 989, 340, 34, 35, 1196, 249, 1294, 114, 80, 1445, 380, 1276, 935, 1242, 224, 106, 104, 1401, 622, 371, 162, 333, 927, 1022, 1000, 930, 1197, 1116, 903, 1435, 91, 1346, 602, 245, 535, 941, 230, 231, 232, 991, 248, 1111, 1029, 742, 222, 797, 254, 416, 1010, 92, 687, 1304, 187, 502, 1124, 174, 537, 1199, 302, 1339, 1001, 1351, 1307, 173, 134, 1137, 282, 483, 96, 847, 1068, 760, 1008, 1213, 1092, 1151, 1268, 955, 711, 1145, 514, 269, 1273, 66, 1157, 1119, 702, 860, 685, 686, 942, 181, 357, 1190, 961, 287, 948, 509, 619, 185, 1104, 887, 394, 304, 863, 799, 1224, 1225, 1021, 1422, 1033, 1136, 998, 154, 834, 1150, 1091, 832, 311, 142, 388, 599, 1188, 217, 235, 236, 1031, 1030, 956, 850, 250, 1097, 904, 199, 328, 182, 294, 103, 1066, 77, 122, 810, 184, 474, 471, 962, 138, 1182, 1090, 549, 1065, 1376, 1433, 1355, 689, 163, 631, 1303, 1155, 558, 804, 1044, 822, 852, 880, 476, 862, 1280, 1300, 858, 362, 1207, 1076, 874, 1218, 1130, 972, 1313, 710, 934, 645, 855, 583, 178, 94; (3) System Code: 722026; UDI: 00884838054189; System Serial Number: 683, 155, 1051, 1052, 618, 654, 786, 1132, 458, 1100, 770, 436, 1338, 1068, 233, 78, 432, 224, 1072, 796, 93, 543, 1248, 561, 1129, 781, 344, 374, 634, 908, 130, 370, 235, 190, 259, 323, 324, 969, 100, 98, 99, 142, 1246, 601, 877, 221, 204, 843, 1038, 1231, 114, 1287, 878, 558, 391, 633, 389, 1050, 1000, 909, 600, 841, 185, 394, 713, 731, 75, 646, 728, 223, 765, 192, 959, 825, 942, 1192, 990, 381, 774, 368, 245, 484, 485, 648, 966, 1268, 109, 110, 116, 604, 319, 627, 716, 396, 531, 156, 253, 965, 1189, 444, 1126, 1210, 1239, 102, 1215, 696, 562, 297, 560, 11, 832, 335, 664, 845, 778, 215, 935, 782, 614, 222, 205, 115, 284, 694, 74, 838, 244, 973, 985, 101, 855, 287, 378, 612, 725, 914, 805, 622, 234, 1293, 121, 512, 1205, 559, 79, 617, 1101, 738, 957, 431, 201, 1340, 122, 653, 663, 688, 563, 704, 462, 191, 931, 967, 265, 826, 998, 534, 807, 961, 962, 986, 1049, 707, 1115, 759, 866, 638, 830, 271, 813, 775, 1316, 343, 406, 252, 748, 616, 1278, 1104, 446, 557, 1368, 358, 310, 497, 977, 471, 334, 65, 461, 1001, 806, 769, 143, 711, 257, 881, 581, 576, 1127, 1128, 1258, 1307, 311, 90, 1092, 276, 722, 1188, 1326, 809, 1067, 404, 729, 894, 477, 18, 1018, 1201, 1202, 126, 164, 455, 542, 566, 978, 326, 1204, 564, 541, 1227, 1349, 231, 77, 1220, 1221, 746, 448, 650, 401, 794, 146, 69, 681, 690, 545, 1228, 1321, 1071, 188, 189, 174, 387, 1341, 897, 619, 1107, 302, 1033, 804, 677, 678, 424, 1271, 587, 1347, 332, 584, 578, 454, 1037, 354, 355, 709, 1203, 356, 930, 172, 911, 134, 294, 346, 609, 569, 141, 596, 177, 979, 452, 1054, 1093, 1313, 161, 182, 717, 924, 928, 960, 1233, 388, 720, 721, 1117, 96, 1146, 510, 858, 744, 745, 420, 1272, 508, 1249, 494, 459, 193, 423, 590, 364, 1091, 1064, 863, 7, 697, 159, 535, 536, 692, 756, 628, 237, 197, 749, 385, 968, 586, 768, 611, 249, 1148, 1121, 17, 273, 43, 203, 1108, 1264, 1265, 40, 132, 217, 662, 754, 478, 1031, 997, 1026, 1029, 1113, 1123, 1199, 1305, 1329, 1355, 1356, 1360, 1361, 1362, 1363, 1364, 1366, 228, 269, 270, 372, 375, 425, 426, 427, 428, 449, 450, 472, 503, 687, 751, 753, 884, 902, 546, 527, 1301, 322, 944, 136, 179, 373, 104, 64, 1196, 314, 1147, 441, 44, 938, 686, 402, 1019, 31, 430, 580, 439, 15, 599, 679, 1276, 927, 592, 1245, 304, 575, 1173, 589, 763, 180, 594, 723, 700, 1195, 521, 285, 656, 657, 658, 857, 803, 585, 854, 382, 779, 632, 1165, 183, 418, 28, 342, 209, 403, 511, 330, 1218, 91, 71, 525, 1327, 490, 730, 416, 941, 1286, 915, 303, 526, 1229, 643, 125, 726, 505, 846, 128, 637, 300, 429, 119, 792, 348, 435, 810, 995, 1028, 453, 1277, 2, 572, 1005, 1106, 360, 488, 620, 293, 14, 296, 206, 747, 266, 783, 353, 1275, 1118, 689, 540, 166, 351, 1186, 571, 1250, 516, 1034, 631, 1230, 1372, 178, 365, 570, 1046, 1047, 573, 1306, 975, 577, 313, 626, 25, 1255, 1184, 917, 695, 780, 1179, 468, 1208, 480, 23, 913, 1152, 341, 1170, 184, 840, 764, 936, 274, 1053, 635, 606, 1371, 390, 895, 630, 899, 734, 337, 129, 502, 1308, 298, 719, 523, 13, 152, 593, 851, 392, 171, 1303, 349, 727, 383, 520, 1163, 133, 413, 118, 903, 661, 261, 295, 460, 528, 1012, 1013, 1015, 1016, 1177, 33, 347, 871, 880, 299, 24, 1187, 213, 1008, 27, 137, 1011, 226, 940, 1191, 139, 496, 1216, 739, 624, 489, 1185, 507, 1353, 1296, 740, 1044, 1240, 625, 1190, 932, 491, 1070, 148, 487, 1096, 943, 1243, 393, 1097, 836, 1021, 1006, 1241, 1242, 761, 421, 1359, 1194, 476, 666, 1098, 649, 597, 598, 301, 818, 958, 1048, 916, 703, 345, 1289, 812, 325, 1280, 1281, 405, 951, 1171, 328, 1175, 762, 1343, 610, 395, 1145, 470, 509, 1065, 167, 773, 1320, 912, 153, 1138, 1078, 814, 529, 530, 1234, 76, 42, 150, 292, 399, 1174, 1136, 789, 672, 640, 641, 642, 154, 1119, 410, 873, 868, 816, 1086, 898, 551, 847, 766, 888, 445, 699, 1150, 574, 22, 519, 92, 208, 1155, 1213, 970, 1352, 1226, 988, 994, 1169, 210, 362, 752, 732, 659, 956, 1120, 1022, 901, 187, 539, 815, 1133, 1354, 735, 1318, 1261, 1134, 1314, 1315, 1116, 1217, 1282, 1009, 1302, 1076, 1346, 833, 1331, 1337, 1062, 1154, 989, 1336, 1319, 1309, 1310, 891, 1262, 1334, 1339, 1109, 1252, 1342, 708, 1335, 987, 1159, 1266, 1153, 1063, 1292, 981, 948, 859, 579, 1007, 1328, 1010, 1332, 1351, 760, 1256, 984, 1161, 636, 1294, 1122, 939, 1274, 1176, 767, 1269, 1214, 1348, 1270, 1283, 1164, 1135, 1259, 1260, 1312, 1209, 225, 227, 992, 844, 463, 1317, 498, 621, 1094, 147, 433, 434, 493, 62, 1219, 236, 464, 39, 875, 88, 937, 157, 971, 537, 714, 742, 1224, 361, 591, 1137, 785, 651, 1168, 701, 776, 777, 515, 1149, 1206, 1207, 1330, 919, 741, 1279, 1066, 808, 922, 567, 1125, 84, 149, 1024, 715, 333, 338, 565, 1156, 1222, 457, 95, 82, 85, 603, 673, 835, 379, 737, 811, 1144, 377, 1143, 306, 89, 97, 517, 867, 869, 702, 918, 1140, 790, 447, 660, 1370, 357, 1045, 376, 824, 712, 41, 1027, 582, 1020, 200, 684, 81, 279, 736, 652, 1225, 363, 94, 758, 504, 724, 950, 29, 492, 583, 682, 549, 250, 506, 819, 251, 262, 263, 755, 821, 921, 983, 1311, 1158, 1157, 1105, 275, 772, 288, 289, 194, 1023, 456, 199, 784, 216, 900, 315, 1004, 255, 886, 887, 1102, 1002, 107, 308, 414, 1058, 896, 366, 710, 524, 290, 1151, 706, 532, 442, 443, 547, 417, 1357, 38, 870, 1365, 889, 412, 862, 1369, 1090, 305, 163, 411, 466, 105, 1273, 788, 419, 1035, 170, 384, 1344, 1345, 247, 481, 827, 212, 317, 318, 316, 1030, 1178, 1131, 675, 1358, 256, 336, 1322, 623, 1130, 1172, 892, 588, 291, 1257, 743, 408, 286, 1H071046, 1162, 70, 1323, 1325, 260, 106, 83, 876, 211, 655, 568, 198, 268, 495, 974, 793, 160, 907, 486, 1251, 469, 669;