PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (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: 722006; UDI: N/A; System Serial Number: 1706, 1730, 1936, 2250, 518, 1260, 1831, 1095, 1096, 1370, 1564, 2269, 471, 1293, 1762, 1764, 225, 1832, 204, 1818, 778, 2587, 1092, 1273, 2274, 2569, 1425, 1496, 707, 1448, 1466, 2183, 1502, 2201, 920, 1654, 1707, 1206, 637, 1326, 2152, 637220, 2536, 861, 172, 529, 1711, 1201, 1363, 2027, 2187, 730, 616, 550, 2336, 1407, 1259, 1913, 674, 1477, 2454, 1081, 272, 2021, 1118, 2126, 771, 2574, 1740, CV.514, 283, 1323, 1604, 1366, 2606, 268, 2366, 1256, 1755, 2140, 599, 2161, 2612, 683, 1942, 1352, 1780, 2062, 852, 853, 95, 188, 968, 2577, 2585, 722008-358, 1932, 2066, 1139, 285, 1433, 822, 823, 1744, 1747, 1752, 1341, 1601, 269, 2548, 1420, 1328, 1922, 797, 2122, 929, 1827, 316, 1648, 2070, S01H006016/000001, 1439, 1659, 1093, 1886, 1854, 1888, 1587, 705, 2537, 121, 1237, 1490, 1441, 1518, 658, 1896, 141, 90, 384, 1523, 327, 606, 849, 2571, 215, 848, 904, 551, 1469, 1830, 289, 186, 2217, 1629, 1865, 588, 1391, 161, 2568, 886, 1346, 587, 2200, 2522, 535, 2323, 435, 1583, 1585, 1536, 1911, 1174, 1914, 826, 2296, 2608, 1560, 1761, 1550, 1844, 1848, 2045, 1589, 91, 2430, 753, 127, 2297, 1185, 504, 1843, 664, 2199, 1868, 1120, 1941, 2610, 595, 638, 1085, 18268, 723, 893, 2347, 1790, CV.740, 1209, 149, 2523, 1364, 2268, 211, 972, 661, 774, 1729, 1612, 1588, 2530, 1351, 1723, 2002, 1710, 2058, S4F621389A000001, 1872, 2042, 24, 992, 2380, 2525, 828, 91A, 2272, 353, 680, 1169, 1641, 37, 1627, 1338, 2562, 317, 331, 1807, 1476, 469, 1534, 889, 287, 1833, 1733, 2159, 1609, 679, 1731, 633056, 2088, 468, 2564, 187, 1661, 1578, 843, 1987, 2054, 702, 1235, 2143, 2051, 265, 1000, 1653, 167, 314, 2324, 1766, 1473, 2390, 1480, 1881, 2533, 1380, 2198, 168, 1318, 2823014, 2203, 1575, 2283, 1750, 1443, 2256, 780, 1507, 2009, 2195, 810, 1856, 1239, 372, 800, 1050, 1511, 1168, 1631, 1956, 722, 347, 2565, 1147, 553, 2135, 1774, 1446, 1908, 691, 2181, 1977, 1594, 2326, 2110, 1603, 166, 135, 2131, 731, 2425, 2106, 2111, 2112, 308, 2573, 2003, 226, 1978, 72246F, 1696, 52, 1242, 1211, 140, 1177, 1754, 521, 2382, 1890, 2281, 2097, 1600, 2427, 1274, 2147, 2607, 1611, 75289, 1900, 612, 2524, 295, CV.271, 913, 2184, 1637, 1582, 1921, 301, 1615, 1007, 1104, 1845, 641, 1927, 1928, 159, 2570, 1107, 2028, 1621, 1640, 1670, 1114, 1115, 1116, 1127, 1H041985, 1387, 1445, 120, 2462, 43074, 1939, 2301, 1734, 1383, 1046, 1361, 47, 1875, 1276, 234, 878, 315, 655, 914, 1277, 2456, 1302, 376, 767, 221, 1955, 1639, 207, 1727, 804, 2561, 781, 1227, 860, 830, 1289, 1306, 425, 343, 2158, 530, 2155, 2013, 1373, 1983, 2286, 1100, 1270, 1591, 2318, 1022, 1838, 1125, 1089, 511, 1307, 833, 1712, 1198, 812, 2392, 594, 794, 1741, 1349, 1454, 1455, 1456, 1751, 2053, 424, 1917, 1667, 2038, 1460, STOR_DEMO_17391651, 1401, 33, 1965, 2416, 1819, 902, 609, 492, 2104, 2348, 2423, 1925, 346, 1552, 1999, 1704, 2488, 1117, 1295, 2247, 1424, 717, 2137, 2278, 1222, 1253, 1947, 2293, 2079, 2124, 1687, 1129, 2529, 1791, 8, 2584, 2049, 2173, 808, 1158, 590, 2043, 1350, 1213, 994, 1859, 2304, 1692, 1264, 1524, 2528, 740, NA, 31, 2086, 941, 958, 2531, 2046, 2371, 1468, 1801, 2514, 768, 1316, 1075, 2551, 460, 2368, 1193, 1605, 2145, 2176, 1753, 1851, 578, 1708, 2175, 2129, 1317, 589, 1180, 1517, 2580, 687, 1652, 2154, 1203, 2342, 1557, 2527, 2550, 1884, 100079164-1971, 1580, 519, 600, 2373, 417, 2031, 1504, 491, 2179, 1784, 2061, 2538, 2428, 1602, 1542, NL94, 2214, 971, 1997, 1824, 859, 1021, 1802, 2085, 2103, 1452, 1808, 1533, 820, 2541, 462, 63, 2023, 2465, 2182, 2343, 2206, 2411, 1246, 1003, 1509, 659, 2526, 614, 2015, 1969, 866, 2194, 336, 2553, 880, 2555, 922, 1598, 1549, 2034, 689, 2114, 1494, 819, 2040, 2069, 2171, 1062, 1759, 585, 2219, 2228, 2259, 2063, 1823, 608, 1554, 1916, 2279, 2192, 1233, 1793, 1919, 2399, 854, 516, 2039, 1967, 867, 1513, 1031, 1817, 1505, 2288, 1991, 1347, 2292, 1948, 951, 2150, 2434, 1892, 1130, 1617, 955, 1961, 2144, 1344, 1988, 2064, 1284, 1529, 1814, 1515, 284, 1678, 428, 1815, 1463, 2244, 1891, 2305, 1336, 1004, 1106, 1787, 946, 952, 482, 455, 1763, 1985, 1899, 1777, 1968, 2438, 1650, 887, 1992, 2094, 811, 2041, 1840, 2360, 837, 2325, 856, 2022, 408, 2369, 1537, 1893, 1538, 380, 2115, 1715, 925, 2101, 1998, 2109, 1714, 2245, 2314, 2291, 1880, 1561, 873, 1746, 102, 2080, 2255, 2307, 2162, 1530, 2095, 1232, 1343, 1506, 2093, 1348, 704, 1849, 2361, 477, 2611, 1595, 164, 1492, 565, 2532, 1568, 2248, 2552, 2117, 125, , 1397, 1618, 1224, 636, 1949, 1192, 891, 1204, 885, 2010, 374, 1794, 724, 2231, 1876, 1686, 2393, 2334, 1858, 352, 2225, 1392, 1149, 89, 940, 931, 2310, 696, 233, 1658, 151, 963, 1749, 2275, 1408, 2353, 1551, 549, 2067, 2163, 1668, 2547, 1525, 2237, 2230, 259, PSO.6002064, 688, 831, 1690, 1250, 520, 1738, 1281, 1488, 2290, 617, 1056, 936, 581, 1540, 2379, 890, 1330, 2367, 2598, 457, 602, 2493, 1556, 640, 2209; (2) System Code: 722012; UDI: 00884838059054; System Serial Number: 481, 423, 1506, 1713, 1396, 2821, 828, 383, 2942, 2308, 1271, 613, 1945, 1281, 1188, 2323, 369, 160, 124, 848, 2265, 459, 469, 1120, 814, 815, 2610, 278, 297, 352, 511, 856, 560, 2522, 2735, 1645, 1407, 2924, 1608, 2707, 570, 1293, 424, 1047, 274, 2933, 135, 150, 2740, 336, 741, 1649, 2687, 655, 1192, 577, 578, 2203, 1036, 1063, 1209, 2254, 1357, 2835, 2843, 1854, 1084, 1027, 518, 888, 1672, 760, 859, 187, 1908, 1848, 735, 2149, 1923, 277, 1743, 1961, 731, 1724, 174, 1306, 1210, 1545, 1692, 1117, 651, 192, 923, 925, 2150, 2937, 1277, 2855, 2856, 2712, 1478, 1561, 2696, 1430, 1519, 2068, 2138, 2234, 1326, 1943, 1549, 1613, 2006, 2454, 606, 1126, 2721, 377, 758, 1868, 2313, 2658, 1335, 1461, 959, 1455, 2085, 1477, 695, 1336, 2171, 1542, 430, 115, 89, 213, 1119, 2161, 1723, 865, 531, 2202, 2828, 1515, 1285, 2219, 1118, 2269, 767, 1014, 601, 1035, 2286, 2293, 1034, 768, 1948, 670, 1207, 2898, 321, 990, 334, 893, 243, 974, 1656, 1108, 2607, 1166, 2134, 1599, 2929, 1141, 1218, 132, 1683, 684, 2288, 2920, 1002, 244, 319, 1975, 1735, 1408, 483, 484, 615, 1686, 505, 1583, 2305, 2302, 590, 756, 691, 1508, 616, 2896, 1305, 1406, 75, 733, 2722, 2726, 2086, 451, 625, 2883, 1032, 1746, 976, 2518, 1919, 205, 2755, 1714, 1798, 2741, 1104, 1560, 1327, 1301, 1003, 1610, 490, 1083, 310, 611, 1195, 208, 943, 1630, 2201, 1733, 1734, 1054, 1189, 2736, 790, 782, 562, 104, 1594, 971, 476, 1871, 2506, 1726, 2890, 579, 1249, 498, 2057, 2829, 610, 2512, 1586, 1265, 1446, 1344, 513, 67, 1625, 1675, 1307, 2307, 1316, 70, 1593, 2151, 924, 1732, 455, 1113, 66, 68, 2135, 855, 2656, 2292, 412, 1001, 963, 2629, 480, 2496, 320, 1224, 858, 2645, 107, 1447, 1688, 1091, 1254, 1405, 1832, 453, 99, 1456, 1993, 2014, 2022, 640, 2289, 2222, 444, 1212, 1964, 1354, 1918, 852, 442, 1345, 404, 649, 650, 1328, 302, 114, 86, 624, 1664, 1219, 2156, 1607, 76, 325, 1016, 224, 935, 2889, 2092, 1793, 1797, 2509, 1279, 1116, 1359, 2145, 2146, 2148, 2713, 2516, 2899, 2227, 2046, 2166, 464, 2221, 1317, 103, 2063, 2285, 1422, 1616, 1660, 399, 1869, 2857, 197, 2215, 2693, 1805, 234, 323, 2886, 100, 2609, 440, 1077, 2311, 589, 1595, 2939, 2469, 1657, 1537, 2875, 2888, 543, 123, 126, 136, 2614, 1078, 71, 2697, 1807, 1924, 1053, 418, 1148, 1181, 492, 1596, 2484, 948, 1673, 1329, 1803, 2873, 1075, 950, 1512, 1716, 2655, 639, 669, 671, 1922, 568, 2065, 326, 2840, 2841, 2849, 2842, 1947, 1950, 1216, 2901, 2310, 72, 2657, 740, 1652, 1099, 1804, 335, 1092, 597, 446, 2054, 85, 643, 920, 1533, 2774, 1033, 894, 88, 1441, 2723, 1992, 517, 1858, 1559, 566, 2900, 1611, 574, 316, 1796, 2508, 2511, 2892, 1250, 1356, 2015, 2207, 489, 766, 406, 1017, 1020, 1823, 527, 1115, 248, 846, 101, 1661, 952, 953, 954, 2514, 1211, 2309, 878, 1827, 851, 2515, 1037, 823, 1334, 2013, 986, 1960, 2677, 1516, 488, 1097, 1404, 2876, 2653, 676, 1852, 1906, 233, 239, 2881, 1044, 1022, 1023, 2264, 796, 1904, 2926, 2283, 525, 159, 2943, 1806, 1558, 1941, 2319, 594, 926, 1989, 2844, 666, 276, 1440, 1550, 2081, 2692, 2003, 2004, 1842, 331, 1712, 1073, 685, 2760, 542, 1690, 69, 533, 473, 2869, 2868, 1467, 1337, 1282, 718, 1662, 576, 595, 2521, 1570, 1946, 1026, 520, 1269, 2912, 1598, 1038, 1058, 1177, 1062, 1731, 787, 1294, 1324, 2276, 389, 732, 751, 1895, 1900, 1665, 1811, 1255, 797, 1894, 504, 757, 494, 1532, 1098, 580, 1270, 499, 961, 2935, 2951, 1399, 452, 1622, 172, 964, 1513, 1280, 1715, 1167, 93, 470, 1045, 1531, 2133, 2874, 500, 892, 110, 337, 1581, 919, 314, 298, 2353, 1260, 2108, 1655, 1433, 1132, 1909, 1094, 1361, 1492, 1815, 2047, 837, 922, 1681, 2282, 1333, 229, 1504, 328, 781, 774, 962, 1902, 2249, 1708, 674, 1495, 2287, 140, 2891, 1363, 482, 2438, 2466, 2517, 1696, 1448, 678, 546, 806, 1289, 2764, 454, 2294, 1046, 1973, 2637, 994, 1284, 1144, 1145, 223, 1081, 1966, 2037, 2630, 1436, 780, 2502, 632, 863, 2297, 726, 1700, 2880, 1853, 2089, 2045, 2575, 246, 1171, 1341, 2098, 1292, 2476, 2666, 648, 545, 526, 1391, 1972, 271, 629, 125, 2380, 432, 966, 1640, 2568, 1921, 1579, 1248, 1623, 2838, 1290, 1702, 916, 2316, 2887, 2444, 1637, 34, 1082, 762, 2112, 510, 1576, 2123, 769, 119, 2567, 2118, 2919, 2030, 98, 1297, 2103, 1147, 1303, 211, 2703, 2300, 1057, 1554, 1403, 1575, 804, 2120, 2043, 1833, 1745, 1874, 1493, 631, 2418, 155, 556, 1304, 422, 1346, 857, 1840, 2759, 617, 1129, 646, 1577, 598, 1158, 425, 1153, 930, 1052, 2097, 341, 1421, 342, 2945, 1872, 1747, 809, 2359, 795, 462, 1460, 157, 351, 194, 79, 203, 627, 2005, 2362, 327, 2084, 170, 395, 2879, 2335, 2352, 2606, 914, 2706, 1156, 2314, 304, 305, 306, 307, 308, 2913, 861, 1569, 1684, 537, 1444, 993, 995, 1428, 891, 1829, 1382, 873, 874, 2490, 1663, 2897, 353, 57, 1358, 288, 191, 1648, 1818, 1546, 1994, 1615, 835, 2928, 1802, 1838, 1914, 1544, 156, 222, 853, 840, 175, 176, 1261, 1283, 1956, 2917, 2915, 2360, 2361, 2850, 968, 1980, 433, 2628, 872, 413, 1159, 744, 931, 437, 429, 786, 2270, 1878, 1295, 1462, 2941, 567, 1985, 2024, 289, 1982, 2525, 2513, 1398, 1915, 2825, 2460, 2579, 798, 1072, 177, 1888, 1355, 1439, 1090, 1651, 2155, 2580, 1614, 2367, 932, 463, 1172, 2916, 468, 1925, 1060, 267, 2523, 2535, 985, 1822, 1040, 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360, 992, 219, 1825, 1839, 2384, 652, 2364, 1556, 2638, 1008, 2782, 2766, 2299, 2776, 2102, 1435, 2127, 1834, 2372, 2373, 1875, 2659, 829, 1434, 2488, 2826, 755, 2493, 2494, 665, 742, 2376, 1127, 1360, 1349, 391, 2507, 730, 1967, 1996, 2587, 2738, 332, 2180, 867, 2526, 2139, 902, 917, 1366, 2363, 2851, 2777, 2096, 2739, 2594, 2340, 1201, 2556, 587, 2847, 1061, 2072, 1691, 2433, 1861, 1653, 407, 1741, 833, 2725, 2326, 554, 2549, 2429, 214, 779, 2650, 2813, 799, 2101, 2071, 2076, 534, 2617, 1348, 1740, 2471, 813, 1530, 998, 2744, 1266, 2539, 2451, 2530, 2378, 2797, 987, 2228, 2229, 2781, 441, 2442, 60, 2853, 2716, 2546, 2252, 2195, 2808, 895, 509, 1381, 2837, 2593, 112, 2124, 478, 2558, 785, 291, 2387, 2768, 185, 2342, 2673, 1450, 1976, 2016, 1591, 443, 2674, 106, 127, 2461, 382, 661, 1157, 727, 2541, 2803, 1137, 2685, 2732, 2615, 1795, 2689, 59, 1128, 1377, 392, 1134, 2552, 2622, 2798, 1130, 2441, 2786, 296, 2578, 2631, 2778, 1074, 376, 2067, 1978, 1263, 2424, 663, 2459, 215, 871, 1678, 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2121, 2008, 2714, 850, 965, 2688, 2604, 662, 868, 2501, 1483, 1489, 2780, 2439, 1528, 647, 1820, 2618, 1232, 2675, 426, 2583, 2175, 2491, 1984, 2695, 2791, 393, 592, 1371, 1125, 1031, 1085, 1864, 645, 1565, 179, 1372, 945, 1449, 1186, 2078, 1557, 1318, 1264, 1351, 1821, 2077, 1867, 1198, 1812, 2066, 212, 933, 1676, 1634, 536, 1541, 1338, 1520, 1955, 178, 249, 2497, 1418, 1251, 1176, 1417, 2625, 1899, 1454, 1055, 1962, 1015, 1124, 1547, 2663, 2266, 1230, 2772, 1543, 956, 1744, 2110, 1553, 2498, 2505, 2922, 2090, 982, 1639, 657, 2499, 2141, 1619, 143, 1368, 1149, 292, 113, 2458, 105, 1742, 1949, 1850, 1901, 845, 2100, 273; (3) System Code: 722028; UDI: 00884838054202; System Serial Number: 1756, 1569, 1956, 129, 1233, 2206, 1690, 928, 1774, 2502, 317, 869, 668, 1017, 406, 540, 548, 590, 596, 1957, 110, 2261, 173, 1310, 866, 1043, 466, 1077, 877, 896, 987, 995, 1343, 1439, 895, 265, 305, 1154, 1000, 1909, 121, 1716, 1983, 2061, 784, 729, 1393, 1948, 525, 1656, 1461, 209, 825, 408, 570, 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