device · product 1 of 1
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
- Initiated
- March 31, 2016
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 5,066 systems.
App-derived interpretation
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.
Official device-enrichment evidence · Sourced
Software design
Inspect official wording and provenance
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.
Code information
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, 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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.
Distribution pattern
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.