PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

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: 2291 units (493 US, 1798 OUS) Lot/code info: (1) System Code: 722003; UDI: N/A; System Serial Number: 445, 1555, 1084, 1411, 1232, 1259, 1023, 1947, 392, 1133, 1135, 1627, 746, 98, 1078, 367, 1584, 1599, 1153, 1154, 1032, 1694, 259, 1471, 1474, 684, 657, 385, 1551, 947, 1360, 1482, 1489, 177, 1634, 1663, 1704, 1214, 546, 1089, 305, 2936, 92, 1092, 1869, 119, 928, 1449, 1805, 998, 501, 503, 1114, 345, 1443, 1444, 8198, 63, 1189, 1954, 1575, 1728, 1430, 147, 1326, 700, 1446, 401, 1615, 939, 527, 1067, 1787, 1529, 104, 342, 390, 1353, 159, 160, 472, 197, 1349, 1271, 653, 917, 997616, 1072, 1594, 574, 892, 1138, 1001, 1950, 447, 1043, 994, 995, 1514, 1525, 1311, 8091, 1472, 1621, 1622, 72, 1187, 1222, 1948, 963, 1700, 1343, 619915, 1667, 463, 959, 1031, 912, 913, 1647, 521, 590, 591, 855, 328A, 696, 1807, 690, 1714, 37, 1799, 1286, 257, 1188, 940, 1512, 1891, 1223, 640, 103, 24, 406, 467, 285, 1637, 453, 833, 1738, 1749, 430, 1491, 1605, 1130, 5, 674, 639, 797, 1033, 1357, 1632, 1631, 391, 281, 1535, 1038, 1045, 1536, 350, 452, 629, 732, 754, 1056, 810, 1610, 1611, 1804, 1122, 1413, 644, 1059, 513, 1163, 1193, 1549, 418, 1778, 1199, 2933, 517, 1597, 1585, 1063, 1596, 337, 1746, 1747, 1619, 288, 988, 535, 1717, 1641, 1395, 411, 412, 413, 414, 415, 1338, 319, 1706, 1572, 1916, 1282, 789, 614, 763, 728, 605, 622, 492, 1612, 1648, 1613, 1568, 1569, 1685, 948, 505, 566, 1297, 895619, 1277, 321, 239, 1216, 328, 329, 190, 1586, 1492, 863, 1616, 359, 1169, 1118, 230, 1421, 1416, 1260, 1609, 115, 1337, 519, 370, 1155, 13, 162, 1478,

UPC codes

00884838059030, 00884838054189

Source

Official record: FDA (Device enforcement) ↗

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