FDAFDA · Food and drugs·Recall number Z-0352-2025
Philips Zenition 50, Model Number: 718096
Published November 20, 2024 · Recall initiated: October 7, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Distributor
- 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.
- Lot
- 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, 1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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