CLASS II ONGOING Device recall · Reported 20 Nov 2024 · FDA Enforcement Report

Philips Zenition recalled by Philips Medical Systems

Philips Medical Systems Nederl is recalling Philips Zenition 50, distributed nationwide in the US. The recall was initiated on 7 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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 recalled986 units (156 US, 29 Canada, 801 ROW)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0352-2025
FDA event ID: 95579
Recalling firm: Philips Medical Systems Nederl, Best, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 7 Oct 2024
FDA classified: 12 Nov 2024
Reported: 20 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

7 Oct 2024	Recall initiated by company
12 Nov 2024	Classified by FDA	+36 days
20 Nov 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Philips Zenition 50, Model Number: 718096

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 95579

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20 Nov 2024	CLASS II	Philips Zenition recalled by Philips Medical Systems	Philips Medical Systems Nederl	Other	Nationwide

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