PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper Systems (R7.6-R8.1). Labeled as the foll

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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, 657, 2141, 1619, 143, 1368, 1149, 292, 887, 113, 105, 1742, 2280, 1949, 475, 1850, 1901, 845, 2100, 273, 1319, 2036, 468, 1341, 545, 526, 769, 1554, 1651, 932, 1060, 1647, 1220, 1200, 1932, 1931, 1935, 491, 514, 294, 1227, 236, 408, 1847, 2089, 873, 874, 1046, 994, 1745, 173, 1700, 2097, 341, 342, 1648, 853, 744, 786, 1355, 1925, 1313, 1991, 373, 1171, 1551, 1794, 2091, 1615, 1439, 1911, 149, 1080, 1, 618, 471, 1844, 1697, 972, 353, 2114, 1283, 1448, 267, 1123, 1206, 497, 425, 1330, 1888, 1050, 2253, 1273, 1974, 1907, 818, 621, 890, 1374, 1747, 162, 1371, 1125, 1031, 1085, 1864, 1565, 179, 946, 1372, 945, 1449, 1517, 1186, 2078, 1318, 1264, 1351, 1640, 1667, 1248, 1637, 1576, 1575, 1493, 646, 1577, 1579, 1574, 329, 2069, 1914, 1173, 343, 304, 306, 307, 308, 1684, 433, 413, 1159, 429, 2010, 1490, 1670, 921, 882, 1051, 2347, 567, 422, 1304, 849, 1853, 1057, 1295, 2055, 603, 1090, 463, 1841, 1129, 1959, 604, 850, 454, 460, 2053, 812, 1468, 1921, 1896, 1982, 1503, 295, 1969, 2130, 411, 183, 375, 969, 1628, 634, 1555, 847, 1666, 240, 1320, 1706, 1528, 241, 242, 157, 156, 804, 1432, 1008, 1068, 658). 4. Model Number: 722013. No UDI. Serial Numbers: 505, 217, 313, 492, 34, 153, 410, 360, 290, 74, 83, 580, 160, 404, 126, 244, 106, 346, 461, 307, 1, 442, 435, 293, 297, 46, 289, 638, 342, 69, 267, 214, 402, 113, 86, 603, 82, 149, 424, 140, 254, 255, 266, 475, 518, 519, 303, 194, 115, 150, 496, 599, 441, 491, 124, 151, 179, 550, 377, 575, 562, 178, 309, 601, 327, 73, 77, 264, 78, 308, 141, 357, 85, 40, 216, 637, 422, 174, 392, 109, 218, 228, 511, 389, 152, 479, 262, 61, 401, 497, 84, 125, 241, 564, 573, 426, 556, 42, 100, 495, 500, 96, 515, 105, 428, 427, 531, 375, 316, 278, 347, 205, 246, 43, 639, 35, 480, 304, 147, 15, 52, 283, 168, 171, 265, 272, 332, 509, 444, 400, 292, 117, 598, 415, 454, 222, 215, 335, 416, 47, 384, 559, 361, 358, 549, 476, 133, 36, 315, 31, 490, 417, 48, 276, 247, 618, 390, 157, 53, 238, 525, 17, 528, 224, 76, 585, 271, 172, 50, 544, 570, 359, 296, 530, 232, 478, 457, 547, 183, 184, 185, 186, 187, 188, 189, 190, 413, 437, 107, 138, 227, 318, 341, 225, 29, 508, 103, 434, 473, 135, 551, 557, 541, 294, 128, 388, 207, 258, 429, 95, 411, 353, 542, 533, 523, 182, 574, 139, 137, 250, 563, 502, 450, 436, 275, 524, 354, 510, 395, 458, 261, 595, 586, 535, 569, 425, 334, 344, 355, 356, 465, 345, 501, 522, 64, 396, 208, 408, 555, 394, 57, 520, 493, 201, 366, 527, 65, 449, 167, 70, 312, 321, 161, 324, 311, 176, 181, 554, 104, 459, 130, 325, 470, 440, 144, 28, 385, 403, 81, 134, 487, 256, 374, 405, 380, 367, 108, 352, 71, 455, 468, 60, 301, 299, 191, 300, 302, 239, 243, 110, 111, 158, 378, 223, 343, 165, 453, 291, 532, 364, 370, 22, 193, 336, 132, 236, 163, 2266, 368, 177, 98, 156, 443, 259, 540. 5. Model Number: 722022. No UDI. Serial Number: 6. 6. Model Number: 722023. No UDI. Serial Numbers: 27, 116, 12, 175, 98, 35, 72, 142, 46, 64, 110, 49, 124, 66, 117, 109, 42, 138, 82, 83, 127, 75, 118, 41, 33, 146, 121, 119, 70, 112, 47, 137, 25, 114, 105, 90, 107, 74, 5, 9, 4, 14, 13, 16, 132, 88, 73, 99, 38, 141, 32, 84, 68, 134, 79, 52, 56, 69, 37, 21, 53, 123, 157, 102, 126, 145, 144, 15, 135, 152, 149, 60, 150, 108, 100, 95, 34, 54, 85, 87, 94, 57, 30, 130, 58, 86, 125, 96, 3, 103, 10, 31, 106, 67. 7. Model Number: 722025. No UDI. Serial Numbers: 3, 2, 6.