Siemens Medical Solutions USA, Inc.: E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.

Recall number

Z-2898-2020

Recalling firm

Siemens Medical Solutions USA, Inc.

Product

E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.

Status

Terminated

Initiated

2016-03-31

Posted

not on file

Terminated

2020-10-29

Reason

E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may lose some detector time information. Our risk analysis indicates that the probability of occurrence is remote. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

Root cause

Software design

Action

Based on the results of our risk assessment indicating that the probability of occurrence is remote, you may continue to use your system. Please ensure that this advisory is placed in the system's instructions for use. To reduce the likelihood of this issue, perform Daily Shutdown and Start-up as described in the operator manual. If you have sold this equipment and it is no longer in your possession, we kindly ask that you forward this notice to the new owner of this equipment. Please inform us about the new owner of the equipment. Adverse events or quality problems experienced with the use of this product should be reported to Siemens through the contact information provided below and may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mailor by fax. If you have any questions regarding this important notice, please contact your local Service representative at the contact numbers provided below. o America: 1-800-888-7436 o Europe, Middle East, and Afr ica: +49 9131 940 4000 o Asia and Australia: +86 (21) 3811 2121

Quantity

5,066 systems.

Distribution

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

Lot, serial or model codes

Model Numbers: 8717733, 8717741, 10275007, 10275009, 10275010, 10607649, 10764801, 10764802, 10764803, 10764804, 10275879, 10413009, 4380213, 4380221, 5242826, 5977066, 5977074, 5984005, 5989079, 5989087, 5989095, 5991109, 5991117, 5992099, 7324143, 7760932, 7761161, 7823920, 7823938, 7823946, 7823953, 7823979, 10151531, 10151532, 10520745, 10607648. E. Cam series serial numbers: 8015, 8061, RC493, 8005, 8660, 8669, 8689, 8687, 8723, 8708, 1078, 1093, 1094, 1104, 1108, 1112, 1207, 11751, 1065, 11623, 1007, 1003, 9965, 8149, 1203, 5130, 1005, 1069, 1073, 1074,1007, 1076, 1080, 1081, 1082, 1095, 1009, 1098, 1010, 1099, 1011, 1109, 1016, 1136, 1137, 1139, 1150, 1151, 1152, 1019, 1155, 1154, 1163, 1026, 1167, 1174, 1176, 1186, 1187, 1188, 1194, 1192, 1211, 1210, 1032, 1220, 1222, 1223, 1233, 1039, 1248, 1247, 1252,1257, 1260, 1259, 1270, 1050, 1280, 1053,1291,1296, 1301, 1321, 1068, 1069, 1347, 1350, 1353, 1078, 1364, 1079, 70001, 70001, 70005, 70006, 70007, 70011, 70010, 70012, 70013, 70015, 70003, 10016, 70017, 70019, 70030, 70031, 70034, 70035, 70037, 70038, 70004, 70040, 70041, 70043, 70044, 70045, 70046, 70047, 70048, 70049, 1014, 1023, 1033, 1037, 1044,1045, 1039, 1051,1054, 1056, 1057, 1003, 1063, 1062, 9995, 1062, 1065, 1096, 1097, 1013, 1124, 1130, 1129, 1147, 1142, 1149, 1156, 1157, 1166, 1185, 1184, 1190, 1203, 1221, 1035, 1271, 1272, 1297, 1304, 1313, 1316, 1320, 1064, 1330, 1357, 1361,1360, 1017, 1027, 1029, 1034, 1036, 1040, 1041,1060, 1059, 1061,10319, 1162, 11070.  Symbia series serial numbers: Serial No 1001, 1002, 1008, 1001, 1007, 1348, 1012, 1001, 1014, 1009, 1433, 1011, 1015, 1482, 1018, 1007, 1003, 1004, 1008, 1023, 1011, 1024, 1026, 1028, 1029, 1013, 1038, 1008, 1015,1009, 1011, 1012, 1013, 1015, 1016, 1040, 1045, 1017,1019, 1018,1049, 1022, 1034, 1025, 1056, 1026, 1038, 1027, 1058, 1028, 1029, 1030, 1025, 1027, 1028, 1031, 1032, 1039, 1034, 1038, 1039, 1041, 1042, 1043, 1040, 1044, 1051, 1045, 1005, 1052 1054 ,1055, 1057, 1005, 1009, 1015, 1030, 1038, 1067, 1073, 1002, 1116, 1128, 1144, 1143, 1152, 1156, 1167, 1007, 1181, 1186, 1189, 1190, 1191, 1011, 1205, 1222, 1224, 1240, 1242, 1246, 1247, 1251, 1015, 1249, 1275, 1280, 1281, 1284, 1285, 1289, 1017, 1308, 1326, 1327, 1342, 1348, 1350, 1351, 1026, 1027, 1358, 1361, 1364, 1029, 1030, 1387, 1400, 1411, 1417,1421, 1427, 1437, 1445, 1482, 1484, 1485, 1045, 1501, 1503, 1509, 1517, 1518, 1528,1533, 1537, 1542, 1549, 1550, 1055, 70003, 1057, 1655, 1657, 1658, 1659, 1062, 1662, 70010,1065, 70011, 70012, 1676, 70013, 1677, 1067, 70015, 1068, 70018, 1150, 1306, 1001, 1011, 1012, 1065,1068, 1078, 1082,1001, 1083,1004,1103,1105,1109,1129,1147,1347,1384,1410, 1144, 1204, 1281, 1297, 1314,1050,1051,1052,1056,1057,1437,1058,1441,1090,1091,1119,1092,1252,1161,1120,1122,1121,1124, 1123, 1125, 1126 ,1131, 1170, 1128, 1129, 1132, 1133, 1134, 1175, 1135, 1136, 1137, 1138, 1139, 1142, 1143, 1180, 1182, 1145, 1146, 1147, 1187, 1148, 1150, 1149, 1152, 1191, 1189, 1154, 1155, 1159, 1158, 1162, 1161, 1160, 1163, 1198,1164, 1165,1169,1168, 1172, 1171, 1203, 1202, 1204, 1170, 1179, 1180,1177, 1178 ,1182, 1183, 1206, 1056, 1184, 1186, 1187, 1191, 1192, 1057, 1194, 1197, 1196, 1195, 1094, 1095, 1208, 1198, 1097, 1099, 1100, 1201, 1203, 1205, 1207, 1208, 1066, 1104,1212, 1210, 1214, 1211, 1107, 1215, 1064, 1218, 1217, 1216, 1220, 1219, 1222, 1108, 1111, 1225, 1069, 1113, 1074,1114,1229, 1230, 1231, 1232, 1071, 1117, 1235, 1233,1236, 1234, 1241, 1242, 1244, 1243, 1245, 1240, 1247, 1086, 1246, 1248, 1121, 1249, 1250,1076, 1123, 1253, 1077, 1087, 1255, 1254, 1078, 1257, 1090, 1256, 1259, 1262, 1258, 1264, 1263, 1266, 1091, 1267, 1270, 1271, 1082, 1269, 1083, 1084, 1276, 1284, 1283, 1286, 1285, 1287, 1288, 1291,1290, 1131, 1295, 1296, 1298, 1300, 1303, 1299, 1302, 1301, 1304, 1308, 1305, 1306, 1088, 1313, 1099, 1311, 1101, 1102, 1319, 1318, 1321, 1322, 1323, 1320, 1138, 1091, 1139, 1327, 1329,1328,1144, 1332, 1334, 1335, 1145, 1337, 1094, 1095, 1096,1341,1338, 1347,1346,1098 ,1099,1349 ,1101,1150, 1350, 1351, 1352, 1152, 1354, 1114, 1104, 1356, 1105, 1366, 1363, 1367, 1116, 1070, 1365, 1364, 1108, 1368 1372 ,1369, 1373, 1375, 1376, 1374, 1071, 1381, 1382, 1384, 1383, 1111, 1385, 1389,1075, 1390,1391, 1393,1165,1395,1394, 1128, 1398,1167, 1168, 1130, 1405, 1404, 1403, 1169, 1411, 1408, 1410, 1412, 1409, 1413, 1417, 1418, 1419, 1120, 1421, 1423, 1424, 1425, 1428, 1427, 1429, 1430, 1176, 1432, 1179, 1180, 1083, 1182,1440, 1184, 1185, 1442, 1443, 1445, 1448, 1449,1446, 1444, 1084, 1450, 1451, 1454, 1455, 1086, 1461, 1192, 1134, 1462, 1463, 1162,1135 ,1466 ,1468, 1195,1171, 1469, 1470, 1090, 1175,1471, 1139, 1176,1472,1094,1178, 1179,1479,1480, 1142, 1098, 1483,1144, 1145, 1185, 1186, 1486, 1146, 1487,1100, 1491,1489,1488,1492,1493,1192,1193,1102, 1194, 1195, 1151, 1203, 1152, 1495, 1496, 1497, 1104, 1204,1205,1105, 1500,1501,1504, 1502,1506,1511,1509,1508,1510, 1517, 1157, 1158, 1513, 1512, 1515, 1518, 1206, 1159, 1519, 1521, 1520, 1209, 1210, 1160, 1523, 1525, 1524,1526,1161,1110,1162, 1211,1530, 1164, 1211, 1212, 1216, 1217, 1535, 1536, 1115,1213, 1540, 1542,1229, 1541, 1544, 1234, 1546, 1236,1237, 1550, 1553, 1551, 1552, 1555, 1556, 1216, 1174, 1558, 1559, 1242, 1561,1560, 1563, 1566, 1568,1567, 1569, 1570, 1180, 1573, 1253, 1576, 1183, 1184, 1578, 1257, 1186, 1582, 1258, 1583, 1130, 1586, 1262,1585, 1584, 1588, 1566, 1593, 1592, 1266, 1190, 1595,1594, 1267, 1597, 1596, 1599, 1600, 1273, 1603, 1606, 1605, 1607,1608, 1137, 1138, 1139, 1613, 1278, 1614, 1280, 1617, 1196, 1615, 1619, 1143, 1282, 1622, 1624, 1626, 1625, 1628, 1201, 1632, 1290, 1291, 1149, 1634, 1151, 1636, 1631, 1637, 1638, 1639, 1158, 1641, 2006, 1643, 1645, 2008, 2009, 1650, 1652, 1654, 1655, 1656, 1660, 1661,1662, 1663, 1307, 1664, 1665, 1310, 1170, 1668, 1672, 1670,1671, 1673, 1181, 1212, 1676, 1677,1678, 1182, 1679, 1315, 1682, 1680, 1683, 1217, 1684, 1317, 1685, 1319 , 1690, 1689, 1692, 1691, 1694, 1693, 1695, 1321, 1697, 1322, 1223, 1702, 1701, 1703, 1704, 1198, 1705, 1202, 1706, 1707, 1708, 1334, 1225, 1709, 1710, 1711, 1712, 1713, 1227, 1336, 1715, 1228 , 1338, 1229, 1339, 1719, 1717, 1718, 1716, 1231, 1723, 1232, 1343, 1722, 1217, 1724, 1725 ,1234, 1727, 1728, 1348, 1729, 1349, 1732, 1731, 1733, 1735, 1737, 1354, 1736, 1738, 1739, 1740, 1225, 1743, 1741, 1742, 1744, 1745, 1236, 1237, 1356, 1229, 1748, 1358, 1359, 1750, 1751,1363 ,1752 ,1753 ,1754 ,1364, 1235, 1755, 1756, 1237, 1240, 1759, 1242, 1760, 1761, 1762, 1763, 1764, 1365, 1767, 1766, 1367, 1246, 1768,1770 , 1247, 1773,1774, 1771, 1250, 1249, 1251, 1371, 1783, 1786, 1252, 1784, 1785, 1253, 1790, 1789, 1791, 1792, 1373, 1374, 1794, 1793, 1795, 1798, 1797, 1799, 1378, 1801, 1796, 1805, 1381, 1804, 1382, 1806, 1807, 1809, 1383, 1808, 1810, 1264, 1261, 1812, 1384, 1262, 1263, 1814, 1815, 1813, 1818, 1816, 1817, 1386, 1819, 1820, 1823, 1822, 1824, 1826, 1825, 1827, 1828, 1267, 1829, 1830, 1831, 1390, 1832, 1833, 1835, 1394, 1284, 1840, 1837, 1396, 1839, 1842, 1841, 1397, 1844, 1398, 1845, 1399, 1400, 1846, 1847, 1850, 1851, 2003, 1853, 1856, 1855, 1854, 1858, 1860, 1859, 1861, 2007, 2003, 2009, 1862, 2004, 1863, 2005, 2006, 1865, 1405, 1864, 1866, 1868, 1872, 2010, 1408, 2016, 1869, 1871,1870, 2018,1873, 1410, 1874, 1876, 1411, 1877, 1412, 2011, 2012, 1413, 1414, 1878, 1416, 1879, 1880, 1881,1883, 1885, 1886, 1888, 1889, 1890, 2001, 1898, 1896, 2025, 1897, 2003,1902, 2004, 2030, 1903, 1904,1905, 2005, 1907, 2021, 1909, 2006, 1920, 2007, 1949, 1948, 1950, 1951, 1112, 1113,1150, 1153, 1152, 1114, 1154,1115, 1118, 1144, 1168, 1167, 1169, 1177, 1151, 1193, 1188, 1199, 2008, 1268, 1282, 1293, 1312, 1422, 1434, 1465, 1499, 2024, 2014, 2015, 2002, 1006, 2004, 1011, 1013,1010, 2001, 2003, 2002, 2005, 2007, 1005, 1006, 2012, 2013, 1008, 2012, 1012, 2004, 2005, 2007, 2008, 2010, 2018, 2012, 2019, 2014, 2015, 2021, 2022, 2020, 2016, 2020, 2022, 2018, 2031, 2019, 2020, 2021, 2023, 2024, 2025, 1012, 2026, 2033, 2027,1016, 1002, 2029, 2038, 2030, 2039, 1018, 2031, 2032, 2033, 1023, 1024, 2036, 1027, 2034, 1029, 1028, 2035, 1032, 1003, 2038, 1004, 1005, 2039, 2048, 1040, 2040, 1006, 2041, 2049, 1007, 2050, 1008, 1009, 2051, 1010, 1011, 1075, 1076, 2038, 1012, 2039, 2040, 2054, 2046, 2047, 1014, 2041, 2042, 1018, 2100, 1020, 1053, 1019, 2059, 1058, 2049, 2049, 2050, 2052, 2051, 1023, 1062, 1063, 1024, 2059, 2047, 1025, 2109, 1911, 1910, 1912, 1913, 1914, 1915, 2016, 1916, 2017, 1919, 1918, 1922, 1924, 1923, 2030, 2019, 1925, 1926, 1931, 1935, 1937, 1936, 1938, 1939, 1940, 1941, 1945, 1946, 2004, 2005, 2006, 2007, 2012, 2013, 2014, 2015,2016 , 2017,2018 ,2021, 2022, 2023, 2024, 2030, 2029, 2031, 2032, 2037, 2040, 2042, 2036, 2041, 2047, 2048, 2049, 2050, 2051, 2052, 2057, 2056, 2060, 2058, 2062, 2061,2063, 2064, 2065, 2067, 2068, 2066, 2069, 2071, 2072, 2075, 2073, 2078, 2079, 2080, 2082, 2083, 2084, 2085, 2086, 2087, 2089, 2091, 2092, 2094, 2093, 2096, 2095, 2097, 2099, 2102, 2103, 2104, 2105, 2110, 2111, 2113, 2115, 2117, 2119, 2118, 2120, 2121, 70017, 2063, 2080, 2067, 2068, 2069, 2070, 2071, 2072, 1110, 1027.

510(k) numbers

["K142006"]

PMA numbers

not on file

Product code

KPS

Firm FEI

1000514697

Firm city

Hoffman Estates

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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