—#210989

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.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K161563
Affected 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.

Why it was recalled

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.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Philips Medical Systems notified consignees on 11/11/2024 via letter. Consignees were instructed that affected systems may continue to be used in accordance with their Indications for Use and Instructions for Use (IFU), to keep the Urgent Medical Device Correction letter with the documentation of the system until Philips corrects the system, circulate this notice to all users of the system so that they are aware of the issue, and if you experience erratic movement of the C-arm and/or if you see a portion of black area on the X-ray image, please call your local Philips representative to report the event. Philips will contact all affected customers to arrange for a Field Service Engineer visit to install an updated Lifetime Extension Kit. Consignees were also instructed to notify customers if further distributed and inform Philips about the transfer through the email account: IGT_Recalls@philips.com. Philips requested consignees complete and return the provided response form. On 11/24/2025, Philips sent a follow up letter to consignees to provide an update to the Urgent Medical Device Correction (MDC) issued on 11/11/2024. The updated letter informed consignees that after further technical investigation on both the hydrogen embrittlement and fatigue conditions, Philips has confirmed that these failure mechanisms do not apply to the bolts in question. Therefore, replacement is not required, even after 10 years of use. As a result, the risks and actions outlined in the original MDC no longer apply to affected systems.

Recalling firm

Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-11-11
Posted by FDA: 2024-12-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210989. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.