Philips Zenition 50, Model Number: 718096

Recall: Z-0352-2025 · Reported November 20, 2024

Enforcement

Recall Number: Z-0352-2025
Event ID: 95579
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: November 20, 2024
Initiation Date: October 7, 2024
Classification Date: November 12, 2024
Address: Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands

Description

Reason

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

Code Info

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

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.

Quantity

986 units (156 US, 29 Canada, 801 ROW)