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Recall Observatory FDA recall evidence

Device product

Philips Zenition 50, Model Number: 718096

Z-0352-2025

October 07, 2024

Class II

Product summary

Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Event
Event 95579
Status
Ongoing
Classification
Class II
Quantity
986 units (156 US, 29 Canada, 801 ROW)
Official record key
device-enforcement:Z-0352-2025

Official wording

Reason: Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.

Code information: Model Number: 718096; UDI-DI: (01)00884838091535(21); Serial Numbers: 792, 1762, 1763, 1748, 236, 1310, 1311, 1764, 1078, 1759, 1760, 1761, 317, 1297, 75, 73, 939, 1517, 877, 1857, 50, 1286, 296, 580, 147, 477, 1681, 1288, 875, 1309, 466, 467, 1192, 1369, 386, 387, 52, 51, 1689, 1691, 1692, 1807, 4, 1690, 1693, 415, 1561, 1269, 432, 798, 799, 858, 860, 936, 944, 602, 676, 701, 702, 704, 705, 706, 293, 1895, 703, 859, 862, 863, 1010, 619, 650, 649, 674, 1806, 632, 613, 651, 750, 559, 1030, 886, 486, 487, 1356, 558, 560, 593, 1259, 1703, 1025, 1537, 139, 1206, 1207, 648, 1208, 1110, 372, 1392, 1607, 1248, 1687, 1688, 1686, 1168, 1700, 1232, 1256, 1550, 1068, 814, 1601, 1534, 1800, 1859, 1911, 1390, 975, 1321, 1251, 1673, 1793, 1794, 1795, 1796, 1942, 1249, 1250, 1252, 1253, 1338, 1340, 1342, 1532, 1533, 1684, 345, 400, 401, 402, 615, 617, 618, 768, 769, 770, 771, 772, 773, 774, 775, 620, 1405, 972, 1812, 1339, 1936, 1937, 1938, 1939, 596, 616, 111, 776, 428, 905, 1408, 1355, 1772, 1773, 678, 1313, 1831, 382, 904, 407, 187, 595, 1270, 1469, 546, 238, 479, 727, 728, 1854, 67, 578, 1801, 943, 223, 94, 1128, 1129, 248, 1016, 1211, 1788, 938, 1105, 1708, 1898, 497, 1672, 462, 1067, 1838, 435, 62, 63, 65, 1071, 810, 589, 590, 1073, 587, 1604, 380, 445, 140, 206, 146, 551, 1597, 91, 460, 47, 5, 92, 1069, 441, 459, 229, 24, 871, 586, 1225, 437, 1315, 143, 23, 1671, 1032, 622, 1538, 1033, 1634, 638, 259, 189, 1685, 191, 195, 1782, 689, 1092, 1224, 1755, 1015, 1057, 1351, 1832, 1833, 1667, 1555, 1187, 1527, 1528, 1214, 930, 1410, 1526, 866, 1220, 1529, 1221, 110, 1215, 1698, 929, 1011, 955, 1218, 1411, 1912, 1914, 1081, 1091, 654, 1352, 1769, 1535, 969, 200, 600, 1923, 1694, 1086, 793, 1654, 57, 512, 58, 608, 1231, 1683, 636, 971, 221, 1554, 1696, 1337, 1370, 1064, 362, 1599, 1357, 507, 594, 1054, 1810, 348, 688, 1605, 584, 430, 1877, 335, 336, 337, 338, 340, 341, 342, 343, 344, 367, 405, 76, 1205, 391, 1875, 1874, 1399, 1520, 1523, 1400, 1087, 1855, 516, 1768, 1201, 1846, 1185, 1562, 1525, 1867, 263, 1521, 923, 1975, 1870, 1976, 1422, 1853, 1198, 1659, 885, 1880, 1619, 1391, 783, 1582, 1883, 723, 1581, 1415, 1620, 79, 1296, 56, 720, 1341, 49, 1887, 876, 882, 888, 924, 935, 1402, 605, 606, 947, 683, 684, 1278, 1279, 1280, 1282, 1283, 1284, 1285, 1616, 1844, 1809, 1281, 207, 681, 682, 1088, 680, 1141, 1845, 320, 598, 270, 691, 788, 1567, 653, 1055, 542, 426, 427, 547, 524, 1090, 846, 456, 163, 205, 847, 505, 475, 476, 250, 1127, 1553, 1531, 1468, 1556, 1825, 1056, 1362, 1758, 1014, 1414, 968, 1602, 976, 977, 1372, 1603, 806, 1676, 1378, 1083, 1642, 1052, 1181, 1353, 1518, 1416, 951, 1780, 614, 949, 1701, 1702, 1989, 940, 510, 1822, 1821, 1066, 1239, 220, 898, 261, 494, 495, 1516, 1080, 87, 361, 357, 873, 899, 1519, 1826, 1147, 1097, 1682, 179, 180, 181, 1336, 1118, 766, 1074, 178, 1095, 188, 1034, 1035, 765, 1349, 767, 1199, 1200, 265, 1551, 421, 1036, 1814, 1749, 227, 228, 461, 1670, 1119, 256, 960, 961, 1076, 1404, 318, 142, 45, 46, 588, 519, 216, 359, 48, 96, 1360, 1358, 1359, 1652, 1900, 1365, 131, 1028, 126, 1649, 1367, 1019, 1020, 1102, 1178, 1180, 1216, 1217, 1219, 1272, 130, 132, 1375, 1542, 1543, 1547, 1600, 1661, 173, 20, 374, 540, 818, 928, 1544, 1515, 1179, 155, 1368, 1287, 533, 534, 535, 536, 537, 538, 747, 748, 1364, 667, 1202, 1024, 1879, 1934, 1665, 870, 1223, 133, 1924, 412, 1876, 1366, 1666, 499, 151, 1173, 1545, 473, 1021, 1022, 1273, 1017, 474, 819, 869, 1650, 129, 1171, 1271, 1733, 669, 1881, 1228, 1662, 1744, 1754, 1962, 1925, 666, 1664, 1317, 1318, 1169, 1125, 1226, 134, 668, 1653, 1277, 1274, 413, 532, 128, 373, 1142, 1882, 127, 1820, 1734, 1660, 1657, 1541, 1878, 1548, 1549, 1546, 1663, 1510, 1059, 1060, 1489, 1482, 1491, 1498, 1503, 983, 1496, 1507, 1001, 1493, 1735, 1508, 989, 1513, 1000, 1005, 1472, 1474, 1637, 1473, 1486, 1006, 1481, 993, 995, 1497, 1487, 1566, 1490, 1640, 1007, 1495, 992, 1470, 1471, 1488, 1739, 1740, 1003, 1501, 1509, 1639, 1478, 1564, 1505, 988, 1502, 987, 996, 1500, 999, 1004, 1476, 1477, 1479, 994, 1512, 985, 1484, 1504, 1641, 984, 1061, 1480, 1511, 1485, 990, 1494, 1475, 986, 1062, 1008, 1565, 1506, 1093, 1492, 997, 1058, 1738, 1736, 1737, 1638, 1002, 252, 1103, 973, 710, 838, 719, 1730, 1731, 22, 1906, 1255, 1861, 234, 282, 161, 1100, 1096, 1101, 1139, 1893, 1894, 1787, 1813, 1149, 268, 269, 716, 1628, 1904, 1705, 1706, 1098, 1099, 81, 465, 576, 1967, 1677, 1678, 1889, 1785, 1786, 1789, 1154, 1150, 1849, 1905, 966, 1974, 1630, 310, 731, 732, 280, 1151, 1254, 398, 1784, 184, 753, 1193, 272, 1148, 212, 553, 285, 258, 439, 1229, 1293, 233, 235, 717, 1783, 1230, 1292, 1294, 1257, 1258, 1598, 1751, 1750, 953, 1260, 1262, 213, 379, 922, 1212, 1213, 1840, 1699, 1209, 1210, 1596, 313, 934, 687, 565, 1847, 215, 1697, 394, 395, 1571, 1572, 946, 1835, 1746, 641, 1043, 1244, 1247, 892, 1871, 974, 1275, 1276, 921, 514, 887, 1267, 920, 1766, 399, 1407, 1343, 1344, 937, 1156, 791, 918, 926, 917, 1195, 709, 879, 1331, 160, 1308, 1522, 1728, 113, 15, 16, 18, 19, 915, 1778, 1808, 315, 1776, 1777, 1779, 1816, 1720, 1726, 1721, 914, 916, 957, 1804, 1406, 70, 624, 1333, 290, 1348, 1373, 1376, 1117, 980, 782, 1330, 1765, 289, 1792, 1802, 1817, 1818, 1727, 390, 1729, 1724, 956, 1644, 1645, 1389, 404, 502, 742, 1752, 1791, 1345, 157, 417, 83, 308, 1767, 642, 1398, 1145, 1606, 738, 1722, 254, 1397, 1781, 1346, 952, 150, 1379, 1380, 839, 1188, 1189, 1803, 919, 693, 1396, 85, 1146, 903, 209, 1347, 1304, 1306, 1307, 8, 1196, 1332, 1334, 1305, 629, 779, 1467, 1797, 739, 808, 1790, 166, 333, 350, 760, 1725, 585, 1335, 101, 1834, 1266, 14, 309, 1723, 1575, 1576, 194, 878, 780, 1268, 13, 963, 890, 893, 991, 244, 245, 246, 1719.

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French Guiana, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Lao People's Democratic Republic, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, R¿union, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam, Yemen.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.