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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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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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, 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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, 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- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
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⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Medical Solutions USA, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 Codes/Lot Numbers:
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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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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2898-2020
Related Recalls
MAMMOMAT Inspiration;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Fusion;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
MAMMOMAT Revelation;
Siemens Medical Solutions USA
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.