PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Hazard

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Details from the source

Reason for recall: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted. Distribution: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, H Quantity: 2317 units (497 US, 1820 OUS) Lot/code info: Model Numbers: (1) 722003, (2) 722010, (3) 722026; UDI-DI: (1) N/A, (2) 00884838059030, (3) 00884838054189; Serial Numbers: (1) 1343, 1349, 1153, 1154, 1472, 257, 1694, 746, 745, 1599, 501, 503, 1360, 959, 1138, 490, 1188, 1532, 940, 1214, 401, 1627, 1031, 1728, 1189, 285, 1311, 1700, 998, 1187, 1222, 305, 1353, 939, 1326, 445, 1223, 700, 657, 527, 1634, 1023, 917, 1043, 994, 995, 945, 521, 590, 591, 855, 491, 1615, 1732, 1761, 1078, 367, 690, 1529, 385, 997616, 1085, 1663, 653, 1667, 928, 1449, 968, 1286, 72, 1622, 1621, 472, 1799, 463, 619915, 696, 1525, 1514, 574, 306, 1114, 1584, 447, 1950, 1647, 406, 1555, 1482, 1489, 1443, 1444, 1072, 1954, 1704, 1232, 749, 1266, 1089, 259, 1259, 1787, 345, 640, 37, 1714, 546, 1133, 1135, 1032, 1512, 892, 684, 857, 1084, 1067, 2936, 1411, 947, 197, 392, 1271, 1807, 1805, 1575, 963, 1430, 8198, 1869, 1594, 467, 1551, 1947, 390, 342, 368, 912, 913, 8091, 1471, 1474, 1446, 1001, 1092, 1718, 1637, 453, 833, 430, 1738, 1749, 1491, 1605, 1130, 5, 639, 674, 797, 1033, 1357, 1632, 1744, 281, 391, 1535, 350, 452, 629, 732, 754, 1038, 1045, 1536, 1056, 599, 1331, 756, 1351, 1611, 1610, 1804, 1122, 1413, 644, 545, 1059, 1327, 513, 1163, 1204, 1193, 1549, 418, 1778, 955, 1199, 2933, 517, 1597, 1585, 1063, 1596, 1341, 337, 1746, 1747, 1619, 288, 988, 535, 1717, 319, 411, 412, 413, 414, 415, 1395, 1338, 1706, 1572, 1916, 1282, 789, 790, 614, 763, 728, 605, 622, 492, 1612, 192, 1613, 1648, 1568, 1569, 1570, 1685, 1314, 948, 505, 566, 1297, 895619, 110

UPC codes

00884838059030, 00884838054189

Source

Official record: FDA (Device enforcement) ↗

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