Z-2898-2020Class II

E.cam or Symbia systems that use foresight detectors -

Name: Z-2898-2020 E.cam or Symbia systems that use foresight detectors -
Creator: Siemens Medical Solutions USA, Inc.
Published: 2016-03-31
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-03-31 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc. began a recall of 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... on 2016-03-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2898-2020
Classification: Class II
Status: Terminated
Initiated: 2016-03-31
Posted: 2020-08-27
Terminated: 2020-10-29
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.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: 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 tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2898-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2898-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-27

Product code KPS

K142006Class IISymbia 6.0Siemens Medical Solutions USA, Inc. / cleared 2014-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)