Summary
The FDA issued a Class II for Philips Zenition 50, Model Number: 718096 by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure..
Details
Source
Device Recall
External ID
Z-0352-2025
Action Date
2024-11-20
Status
Ongoing
Category
device
Product Description
Philips Zenition 50, Model Number: 718096
Lot/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.
Quantity Affected: 986 units (156 US, 29 Canada, 801 ROW)
Reason for Recall
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-07
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 242 device recalls issued in the same week, part of 413 device-related FDA actions this month.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have FDA actions?
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0352-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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