PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

Hazard

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Details from the source

Reason for recall: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Quantity: 5084 units (1616 US, 3468 OUS) 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, 1

UPC codes

00884838059054, 00884838054202

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.