Recall Weekly
Moderate riskFDA DeviceClass II

Philips ALLURA Xper FD20 X-ray system recalled for foot switch malfunction

Philips has identified a problem with the wired foot switch on certain ALLURA Xper FD20 X-ray systems where imaging may not start or may start intermittently. This affects specific serial numbers across three system codes. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. Check if your ALLURA Xper FD20 system serial number matches the recall list
  2. Contact Philips Medical Systems for instructions on the foot switch remedy
  3. Do not rely on the foot switch until you receive guidance from Philips
  4. Report any imaging failures or safety concerns to your device service representative
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 22 products — see all of them.

Details

Units affected
5084 units (1616 US, 3468 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 6, Best, Netherlands
Classification
Class II
Recall number
Z-1663-2026

In the FDA's words

Description
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. (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, 6
Hazard
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

22 products in this recall

Philips X-ray systems recalled for faulty foot switch

Philips is recalling 22 models of its Allura Xper and Azurion X-ray imaging systems. The recall covers a wired foot switch that may fail to start X-ray imaging or may start it intermittently. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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