Class 2 Device Recall Zenition 50

• Date Initiated by Firm: October 07, 2024
• Date Posted: November 12, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0352-2025
• Recall Event ID: 95579
• 510(K)Number: K183101
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Philips Zenition 50, Model Number: 718096
• 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.
• FEI Number: 3002807880
• Recalling Firm/ Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; Veenpluis 4-6; Best Netherlands
• For Additional Information Contact: Virginia Huete; 31-615-67 92 27
• Manufacturer Reason for Recall: Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.
• FDA Determined Cause: Under Investigation by firm
• Action: On October 7, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. 4. Actions that should be taken by the customer! user in order to prevent risks for patients. " Affected systems may continue to be used in accordance with their intended use and Instructions for Use (IFU). " Establish emergency protocols including back up devices if available in place to manage the situation should you experience this issue during the procedure. " Circulate this Urgent Medical Device Correction to all users of the system so that they are aware of the issue. " Keep this Urgent Medical Device Correction with the documentation of the system until Philips implements the correction in your system. Ensure that the letter is in a place likely to be seen! viewed. " If you experience a power loss issue with your system, report the event to Philips. " Complete and return the attached response form (on page 04) to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction and understanding of the issue and required actions to be taken. 5. Actions planned by Philips IGT (Image Guided Therapy) systems to correct the problem Philips will replace the 5-Ampere MCU board fuse with a 10-Ampere MCU board fuse in all affected systems. Philips will contact customers to schedule a visit to perform this action free of charge (reference FC071800109). This notice has been reported to the appropriate Regulatory Agencies. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, or by regular mail, or by fax. Be assured that maintaining a high level of safety and quality is our highest priority. If you need additional information or support concerning this issue, contact your local Philips representative at 1800-722-9377 (Philips Customer Care Solutions Center).
• Quantity in Commerce: 986 units (156 US, 29 Canada, 801 ROW)
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB