Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638,

Summary

The FDA issued a Class II for Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 51 by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply un.

Details

Product Description

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Lot/Code Info: Product Codes: (1)722012, (2) 722028, (3) 722006; UDI-DI: (1) 00884838059054, (2) 00884838054202, (3) N/A; Serial numbers: (1) 919, 1581, 1117, 1001, 1673, 1712, 585, 517, 1545, 1715, 504, 757, 935, 1356, 1250, 1613, 2006, 1440, 1550, 1733, 1734, 2201, 1922, 741, 2283, 1034, 1359, 1848, 950, 2943, 865, 1908, 1166, 1113, 1804, 100, 1408, 590, 2508, 1279, 2509, 452, 2151, 1724, 2134, 481, 543, 893, 1455, 2085, 423, 1282, 2307, 1798, 1656, 990, 1806, 1871, 2506, 1652, 894, 2920, 1189, 1099, 1038, 1058, 566, 823, 1037, 924, 2319, 2310, 1610, 686, 2933, 2514, 1108, 500, 459, 1422, 1035, 84, 1649, 1895, 1900, 1723, 878, 2221, 464, 2496, 2222, 1515, 1731, 1017, 1020, 380, 1811, 527, 2171, 418, 1053, 1558, 1336, 601, 1014, 1265, 331, 389, 732, 751, 1324, 2276, 684, 2219, 814, 815, 1120, 297, 1713, 580, 1098, 1852, 1307, 1858, 758, 2054, 856, 1690, 1407, 480, 579, 1327, 695, 733, 1506, 1091, 1254, 797, 213, 1280, 828, 1118, 1249, 542, 1033, 2265, 490, 920, 1209, 470, 1075, 2203, 1396, 444, 2092, 597, 1269, 1002, 1023, 2264, 2234, 1805, 1192, 1823, 483, 484, 615, 2150, 892, 1478, 1262, 1688, 1961, 1062, 649, 650, 767, 1641, 1277, 2609, 1975, 316, 959, 1461, 489, 766, 639, 669, 671, 1583, 451, 625, 1047, 670, 1616, 1660, 1807, 1924, 511, 1714, 1406, 492, 352, 643, 577, 578, 1306, 855, 1456, 2269, 1078, 768, 2285, 1793, 1797, 1216, 948, 498, 1570, 2521, 1662, 2313, 1743, 2516, 1561, 1692, 2286, 2293, 1960, 616, 1508, 1084, 655, 1796, 1026, 2629, 1337, 685, 1560, 1441, 2926, 1854, 2288, 473, 2068, 624, 531, 1586, 1617, 1904, 1354, 1918, 1906, 160, 383, 560, 2614, 1948, 1195, 518, 888, 1992, 323, 792, 2003, 2004, 174, 1832, 2166, 562, 1941, 859, 1593, 1608, 731, 520, 1328, 848, 2292, 1946, 1063, 611, 1587, 2308, 613, 1842, 205, 1799, 1665, 187, 1513, 2015, 2207, 2309, 319, 2161, 1116, 1993, 208, 1281, 1945, 1919, 110, 1735, 1326, 788, 488, 1519, 1533, 1334, 2013, 1405, 1141, 923, 925, 406, 1293, 513, 1446, 1625, 1675, 1148, 1181, 2515, 1305, 499, 1716, 476, 1657, 1045, 1630, 2610, 1827, 1923, 1516, 453, 2215, 574, 1611, 1559, 2924, 1686, 858, 1224, 1345, 2057, 1430, 1255, 1599, 2014, 2022, 1188, 1073, 1404, 1664, 103, 2063, 533, 1947, 1950, 594, 1467, 1596, 2607, 926, 756, 424, 1027, 1894, 2145, 2148, 234, 2065, 1477, 2227, 1177, 1645, 2522, 2156, 1167, 1595, 2469, 88, 1672, 1210, 1512, 1101, 1399, 1119, 952, 953, 954, 1661, 320, 455, 570, 1622, 1115, 1316, 1212, 976, 1746, 986, 971, 1594, 239, 640, 446, 1301, 2323, 430, 1542, 1607, 2454, 2149, 1211, 1004, 2046, 1044, 505, 2937, 310, 192, 314, 852, 1097, 1532, 1964, 2135, 1357, 589, 1092, 846, 963, 964, 1658, 1344, 1902, 1909, 1132, 1361, 1504, 1433, 1260, 2108, 837, 333, 1681, 2282, 328, 781, 1815, 922, 1333, 774, 1492, 2047, 1855, 1817, 1562, 627, 2005, 930, 1956, 967, 2168, 910, 1168, 931, 2098, 1421, 863, 1040, 409, 1072, 1332, 2042, 57, 995, 993, 2350, 1460, 1971, 838, 914, 2352, 1156, 180, 1444, 2314, 2335, 795, 1865, 628, 809, 2945, 2406, 1376, 2244, 2169, 194, 664, 482, 1363, 288, 462, 1980, 1580, 395, 1423, 548, 2455, 1887, 1157, 1485, 876, 1592, 2346, 2074, 2072, 1256, 573, 1917, 2418, 2674, 60, 2547, 1833, 2587, 630, 1825, 1839, 1591, 2462, 502, 2599, 98, 1196, 1495, 2139, 2490, 477, 2204, 779, 2558, 2385, 770, 799, 1703, 2178, 541, 1480, 2553, 2545, 608, 2356, 1297, 2026, 652, 1150, 1349, 911, 2585, 871, 1678, 2451, 2413, 2076, 2127, 1671, 1081, 1028, 2056, 1708, 830, 2479, 1978, 2363, 2102, 663, 2474, 839, 2298, 1151, 1152, 1626, 2403, 1882, 569, 688, 2016, 2434, 1366, 2296, 544, 1481, 1390, 419, 2504, 2197, 1436, 2336, 728, 785, 355, 1698, 793, 794, 1556, 1654, 2539, 1736, 2601, 2604, 1967, 622, 1691, 2365, 2366, 2291, 2299, 2501, 1669, 2634, 1471, 737, 1879, 581, 2121, 1937, 2388, 2180, 1342, 647, 867, 1288, 1489, 1178, 1874, 2175, 479, 2537, 1237, 1381, 2274, 398, 2523, 2491, 2459, 1965, 1818, 941, 1147, 803, 1699, 798, 441, 1089, 2429, 1463, 1479, 534, 1138, 2401, 752, 2344, 1536, 2249, 2532, 2410, 772, 1021, 1382, 2441, 2326, 2345, 1999, 2405, 1309, 2438, 1572, 2173, 2174, 1836, 2549, 2583, 730, 2031, 1976, 2118, 1079, 1530, 1875, 593, 2394, 2527, 1412, 1548, 2384, 2153, 748, 2576, 1567, 2411, 1064, 1287, 1795, 635, 2358, 2798, 509, 2577, 1484, 667, 2524, 2443, 2348, 2442, 2330, 659, 528, 1711, 2128, 1056, 1134, 1862, 2470, 1348, 2481, 443, 806, 2396, 407, 1898, 2460, 2467, 405, 2493, 2494, 980, 2058, 1169, 1223, 629, 763, 1535, 2393, 2615, 432, 966, 987, 1631, 2525, 2392, 1233, 2290, 2482, 1234, 2017, 2894, 2526, 2398, 2507, 599, 1705, 1721, 2427, 753, 1624, 2387, 619, 2424, 1462, 810, 771, 266, 2122, 755, 2543, 2647, 1834, 866, 2208, 743, 2633, 1977, 2461, 693, 902, 2613, 2555, 2270, 917, 2371, 2575, 2342, 998, 1131, 2155, 1174, 1375, 982, 1268, 662, 2487, 1885, 2341, 2449, 2028, 2033, 2338, 2389, 679, 376, 1926, 916, 2297, 1623, 660, 1076, 2007, 936, 2453, 2531, 2351, 2546, 2552, 1059, 2616, 2301, 2589, 2188, 588, 2087, 895, 1377, 272, 648, 1860, 2372, 2373, 587, 1614, 2457, 2399, 661, 554, 2608, 1830, 2205, 1086, 2117, 813, 2471, 1819, 2327, 2412, 572, 1861, 2489, 1695, 2343, 726, 2391, 2103, 2414, 2415, 2437, 817, 524, 415, 2095, 2082, 2619, 1145, 631, 1122, 738, 2464, 2593, 2421, 746, 2252, 1222, 112, 2124, 2488, 185, 2404, 2375, 2182, 400, 2340, 1203, 1202, 2080, 869, 2502, 2229, 1415, 764, 2422, 742, 2325, 2067, 2364, 1135, 1881, 2093, 2034, 539, 805, 360, 680, 1450, 2538, 555, 2536, 2492, 1284, 1266, 2094, 1364, 1093, 2008, 773, 2730, 1998, 965, 2112, 556, 1483, 868, 2541, 2024, 2439, 2440, 1232, 1737, 1702, 410, 2554, 2198, 2278, 833, 2591, 2123, 1653, 2177, 1367, 2195, 1388, 2495, 1391, 1261, 557, 840, 437, 1082, 426, 1633, 672, 1379, 872, 692, 1820, 144, 1821, 972, 1837, 1696, 2045, 2919, 2043, 678, 780, 1290, 2517, 246, 34, 1939, 2520, 1585, 835, 1245, 1930, 1897, 2144, 1246, 1494, 1158, 1951, 897, 2137, 2519, 1663, 1153, 609, 2000, 1400, 403, 1013, 2934, 1748, 1845, 1425, 1988, 2312, 777, 749, 1720, 1546, 393, 592, 1870, 510, 2256, 2172, 623, 2316, 2220, 1985, 687, 1915, 1829, 1710, 918, 602, 1322, 745, 1891, 1979, 808, 1719, 465, 1024, 988, 1582, 807, 1048, 529, 617, 834, 985, 2627, 1620, 1121, 421, 1136, 2927, 2918, 2011, 1452, 1534, 1813, 1176, 1520, 1949, 1955, 1541, 1901, 1639, 536, 2266, 2497, 657, 1198, 1634, 1899, 1338, 2498, 1553, 2625, 178, 1840, 212, 2066, 2458, 1619, 1812, 1055, 1251, 1418, 956, 2090, 887, 2100, 1543, 1744, 933, 1676, 845, 2110, 2141, 2505, 292, 1547, 1962, 1124, 2922, 1149, 1319, 2036, 857, 1346, 408, 1847, 2089, 873, 874, 994, 1046, 1700, 1991, 853, 2084, 2362, 342, 2359, 1355, 191, 537, 2360, 2361, 786, 744, 1925, 373, 2097, 1171, 1551, 1794, 2091, 1080, 1615, 1, 618, 1439, 312, 1844, 1911, 1697, 2114, 1283, 497, 1448, 1206, 1123, 1974, 425, 1888, 1907, 1374, 1747, 1264, 1517, 1318, 1085, 946, 2078, 945, 1565, 1372, 1125, 1557, 1186, 645, 1864, 1371, 1449, 1351, 1031, 1574, 1640, 1575, 1576, 1573, 1493, 1248, 1577, 646, 1579, 1403, 1914, 1173, 1227, 1931, 1060, 514, 1651, 491, 932, 1554, 1200, 1647, 1341, 1932, 1220, 526, 1935, 769, 1684, 2602, 2513, 433, 2628, 413, 2606, 327, 2010, 2347, 1051, 567, 422, 1304, 1853, 1057, 1295, 2055, 463, 1090, 1968, 1841, 603, 1959, 1129, 604, 454, 460, 1555, 1666, 1896, 1921, 1320, 1503, 1982, 1706, 295, 1468, 812, 2053, 1008, 804, 658, 1068, 1432, (2) 819, 774, 316, 541, 565, 647, 674, 864, 710, 880, 949, 237, 238, 356, 696, 793, 618, 313, 329, 1024, 904, 284, 167, 207, 208, 526, 479, 431, 601, 869, 377, 275, 2933, 900, 52, 66, 539, 1, 272, 494, 80, 282, 990, 262, 522, 406, 548, 1017, 586, 530, 136, 940, 938, 1076, 929, 251, 731, 989, 981, 350, 125, 368, 971, 499, 211, 261, 924, 934, 721, 1002, 779, 518, 519, 590, 1058, 452, 811, 543, 680, 668, 11, 318, 118, 343, 437, 205, 340, 481, 806, 274, 805, 468, 906, 317, 982, 592, 655, 143, 140, 464, 893, 139, 552, 303, 476, 419, 521, 531, 1014, 861, 580, 256, 818, 254, 326, 122, 324, 130, 877, 987, 995, 267, 866, 895, 128, 449, 516, 408, 373, 154, 956, 496, 376, 744, 473, 630, 785, 553, 110, 983, 627, 903, 784, 422, 525, 363, 260, 339, 781, 809, 678, 528, 560, 743, 445, 161, 189, 292, 720, 173, 620, 361, 281, 475, 315, 908, 672, 132, 141, 145, 180, 570, 463, 1244, 1004, 538, 210, 564, 558, 407, 697, 364, 879, 930, 932, 882, 129, 218, 451, 485, 176, 257, 962, 556, 998, 691, 215, 459, 889, 729, 160, 966, 306, 213, 692, 925, 994, 131, 133, 138, 224, 48, 490, 968, 67, 638, 631, 637, 529, 493, 491, 867, 891, 561, 209, 825, 579, 498, 462, 677, 1043, 142, 280, 159, 169, 535, 386, 158, 922, 184, 185, 489, 466, 671, 217, 194, 197, 227, 402, 559, 967, 973, 1069, 1032, 454, 918, 821, 698, 1051, 675, 741, 768, 910, 666, 547, 550, 416, 394, 636, 901, 426, 1035, 684, 190, 840, 842, 625, 166, 346, 632, 71, 382, 121, 549, 874, 229, 228, 333, 372, 151, 695, 371, 911, 1030, 717, 265, 758, 942, 742, 878, 763, 663, 905, 64, 628, 430, 200, 212, 63, 788, 1008, 1046, 944, 607, 1006, 870, 505, 2924, 770, 997, 748, 247, 460, 728, 951, 440, 536, 264, 30, 298, 300, 993, 405, 639, 467, 546, 855, 823, 835, 948, 2233, 1091, 760, 999, 1038, 487, 1987, 2069, 1594, 503, 915, 510, 603, 604, 876, 711, 708, 1065, 755, 615, 988, 1464, 1512, 507, 508, 735, 736, 737, 838, 969, 907, 1325, 612, 323, 853, 126, 201, 555, 702, 321, 1027, 933, 415, 9, 104, 38, 578, 414, 413, 13, 986, 765, 112, 824, 120, 221, 374, 1443, 661, 980, 165, 164, 1669, 574, 747, 635, 91, 514, 412, 182, 330, 480, 232, 816, 193, 780, 813, 709, 926, 233, 244, 32, 35, 1042, 40, 799, 163, 641, 766, 776, 297, 434, 389, 380, 624, 676, 119, 441, 105, 687, 523, 576, 577, 43, 954, 192, 899, 179, 54, 472, 295, 745, 123, 455, 718, 777, 1517, 730, 492, 762, 851, 568, 1047, 392, 963, 856, 168, 1097, 162, 716, 613, 857, 852, 337, 609, 249, 921, 544, 270, 970, 81, 527, 937, 767, 800, 826, 1021, 679, 301, 150, 156, 919, 606, 557, 483, 395, 1037, 98, 673, 103, 622, 354, 657, 599, 693, 752, 366, 276, 947, 898, 605, 427, 334, 245, 199, 1210, 442, 444, 1302, 782, 939, 617, 186, 1071, 1075, 794, 965, 614, 764, 432, 501, 1704, 367, 545, 438, 832, 286, 99, 29, 802, 398, 23, 608, 1070, 37, 439, 423, 235, 433, 322, 868, 694, 219, 754, 175, 642, 670, 727, 725, 387, 726, 722, 621, 724, 723, 974, 259, 34, 314, 860, 458, 756, 410, 269, 296, 705, 703, 704, 707, 643, 226, 623, 597, 355, 291, 311, 266, 792, 551, 116, 790, 611, 79, 170, 171, 24800-10, 753, 830, 320, 690, 600, 701, 411, 27, 484, 302, 335, 795, 773, 338, 659, 660, 863, 10, 1067, 115, 640, 602, 198, 290, 814, 341, 191, 875, 482, 153, 309, 778, 650, 562, 353, 585, 651, 652, 248, 362, 1079, 738, 319, 506, 2035, 77, 801, 370, 443, 183, 713, 964, 504, 187, 327, 658, 157, 883, 287, 685, 834, 797, 1040, 41, 360, 278, 955, 783, 14, 469, 502, 381, 1018, 975, 803, 733, 113, 225, 588, 573, 844, 845, 846, 1720, 843, 715, 712, 1785, 714, 36, 2490, 149, (3) 530, 1473, 316, 2087, 1637, 317, 1589, 1445, 2097, 810, 1928, 722, 498, 1457, 2536, D902-214-00, 920, 1875, 1520, 2608, 2066, CV.271, 1755, 1120, 904, 1754, 1227, 2574, 1733, 2102, 638, 2002, 723, 2112, 1732, 1870, 674, 1720, 1476, 1935, 226, 1631, 1235, 1469, 1830, 2184, 1448, 551, 1511, 353, 1845, 1653, 633056, 1889, 372, 1648, 722008-358, 1790, 1100, 1373, 1270, 1591, 1022, 768, 2304, 2371, 336, 351, 352, 2046, 555, 125, 1255, 1712, 666, 284, 2416, 516, 455, 1787, 417, 1819, 1880, 867, 1003, 2488, 380, 2438, 1031, 2095, 1784, 2115, 1530, 2245, 408, 245, 428, 1817, 1891, 2061, 833, 2278, 2348, 477, 1554, 1763, 902, 2307, 1561, 1916, 102, 1998, 1948, 2293, 2369, SN002458/100099178, 1692, 2015, 164, 1791, 1668, 585, 2171, PSO.6002064, 259, 1949, 2079, 1568, 241, 424, 872, CV619, 233, 1551, 2010, 89, 940, 2598, 457, 799, 866, 2124, 346, 2520, 2475, 1264, 1687, 1504, 1652, 1203, 519, 100079164-1971, 1213, 1509, 1708, 994, 31, 123456, NA, 1350, 83491, 33, 1533, 1219, 460, 2230, 1618, 717, 1539KR, 1876, 1021, 1559KR, 594, 2528, 2517, 1557, 1408, 462, 1193, 1605;

Quantity Affected: 2114 units (791 US, 1323 OUS)

Reason for Recall

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-09-03

Company