—#122573

Product

Symbia S, Product Usage 1) 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 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. 3) SPECT + CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patients anatomy. .

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041166
Affected lot / code info: Material Number 8717741, Serial Numbers: 1001 , 1002 , 1003 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 , 1015 , 1016 , 1017 , 1018 , 1019 , 1020 , 1021 , 1022 , 1023 , 1024 , 1025 , 1027 , 1028 , 1029 , 1030 , 1031 , 1032 , 1033 , 1034 , 1035 , 1036 , 1037 , 1038 , 1039 , 1040 , 1041 , 1042 , 1043 , 1044 , 1045 , 1046 , 1047 , 1048 , 1049 , 1050 , 1051 , 1052 , 1053 , 1054 , 1055 , 1056 , 1057 , 1058 , 1059 , 1060 , 1061 , 1062 , 1063 , 1064 , 1065 , 1066 , 1067 , 1068 , 1069 , 1070 , 1071 , 1072 , 1073 , 1074 , 1075 , 1076 , 1077 , 1078 , 1079 , 1080 , 1081 , 1082 , 1083 , 1084 , 1085 , 1086 , 1087 , 1088 , 1089 , 1090 , 1091 , 1092 , 1093 , 1094 , 1095 , 1096 , 1097 , 1098 , 1099 , 1100 , 1101 , 1102 , 1103 , 1104 , 1105 , 1106 , 1107 , 1108 , 1109 , 1110 , 1111 , 1112 , 1113 , 1114 , 1115 , 1116 , 1117 , 1118 , 1119 , 1120 , 1121 , 1122 , 1123 , 1124 , 1125 , 1126 , 1127 , 1128 , 1129 , 1130 , 1131 , 1132 , 1133 , 1134 , 1135 , 1136 , 1137 , 1138 , 1139 , 1140 , 1141 , 1142 , 1143 , 1144 , 1145 , 1146 , 1147 , 1148 , 1149 , 1150 , 1151 , 1152 , 1153 , 1154 , 1155 , 1156 , 1157 , 1158 , 1159 , 1160 , 1161 , 1162 , 1163 , 1164 , 1165 , 1166 , 1167 , 1168 , 1169 , 1170 , 1171 , 1172 , 1173 , 1174 , 1175 , 1176 , 1177 , 1178 , 1179 , 1180 , 1181 , 1182 , 1183 , 1184 , 1185 , 1186 , 1187 , 1188 , 1189 , 1190 , 1191 , 1192 , 1193 , 1194 , 1195 , 1196 , 1197 , 1198 , 1199 , 1200 , 1201 , 1202 , 1203 , 1204 , 1205 , 1206 , 1207 , 1208 , 1209 , 1210 , 1211 , 1212 , 1213 , 1214 , 1215 , 1216 , 1217 , 1218 , 1219 , 1220 , 1221 , 1222 , 1223 , 1224 , 1225 , 1226 , 1227 , 1228 , 1229 , 1230 , 1231 , 1232 , 1233 , 1234 , 1235 , 1236 , 1237 , 1238 , 1239 , 1240 , 1241 , 1242 , 1243 , 1244 , 1245 , 1246 , 1247 , 1248 , 1249 , 1250 , 1251 , 1252 , 1253 , 1254 , 1255 , 1256 , 1257 , 1258 , 1259 , 1260 , 1261 , 1262 , 1263 , 1264 , 1265 , 1266 , 1267 , 1268 , 1269 , 1270 , 1271 , 1272 , 1273 , 1274 , 1275 , 1276 , 1277 , 1278 , 1279 , 1280 , 1281 , 1282 , 1283 , 1284 , 1285 , 1286 , 1287 , 1288 , 1289 , 1290 , 1291 , 1292 , 1293 , 1294 , 1295 , 1296 , 1297 , 1298 , 1299 , 1300 , 1301 , 1302 , 1303 , 1304 , 1305 , 1306 , 1307 , 1308 , 1309 , 1310 , 1311 , 1312 , 1313 , 1314 , 1315 , 1316 , 1317 , 1318 , 1319 , 1320 , 1321 , 1322 , 1323 , 1324 , 1325 , 1326 , 1327 , 1328 , 1329 , 1330 , 1331 , 1332 , 1333 , 1334 , 1335 , 1336 , 1337 , 1338 , 1339 , 1340 , 1341 , 1342 , 1343 , 1344 , 1345 , 1346 , 1347 , 1348 , 1349 , 1350 , 1351 , 1352 , 1353 , 1354 , 1355 , 1356 , 1357 , 1358 , 1359 , 1360 , 1363 , 1364 , 1365 , 1366 , 1367 , 1368 , 1369 , 1370 , 1371 , 1372 , 1373 , 1374 , 1375 , 1376 , 1377 , 1378 , 1379 , 1380 , 1381 , 1382 , 1383 , 1384 , 1385 , 1386 , 1387 , 1388 , 1389 , 1390 , 1391 , 1392 , 1393 , 1394 , 1395 , 1396 , 1397 , 1398 , 1399 , 1400 , 1401 , 1402 , 1403 , 1404 , 1405 , 1406 , 1407 , 1408 , 1409 , 1410 , 1411 , 1412 , 1413 , 1414 , 1415 , 1416 , 1417 , 1418 , 1419 , 1420 , 1421 , 1422 , 1423 , 1424 , 1425 , 1426 , 1427 , 1428 , 1429 , 1430 , 1431 , 1432 , 1433 , 1434 , 1435 , 1436 , 1437 , 1438 , 1439 , 1440 , 1441 , 1442 , 1443 , 1444 , 1445 , 1446 , 1447 , 1448 , 1449 , 1450 , 1451 , 1452 , 1453 , 1454 , 1455 , 1456 , 1457 , 1458 , 1459 , 1460 , 1461 , 1462 , 1463 , 1464 , 1465 , 1466 , 1467 , 1468 , 1469 , 1470 , 1471 , 1472 , 1473 , 1474 , 1475 , 1476 , 1477 , 1478 , 1479 , 1480 , 1481 , 1482 , 1483 , 1484 , 1485 , 1486 , 1487 , 1488 , 1489 , 1490 , 1491 , 1492 , 1493 , 1494 , 1495 , 1496 , 1497 , 1498 , 1499 . 1500 , 1501 , 1502 , 1503 , 1504 , 1505 , 1506 , 1507 , 1508 , 1509 , 1510 , 1511 , 1512 , 1513 , 1514 , 1515 , 1516 , 1517 , 1518 , 1519 , 1520 , 1521 , 1522 , 1523 , 1524 , 1525 , 1526 , 1527 , 1528 , 1529 , 1530 , 1531 , 1532 , 1533 , 1534 , 1535 , 1536 , 1537 , 1538 , 1539 , 1540 , 1541 , 1542 , 1543 , 1544 , 1545 , 1546 , 1547 , 1548 , 1549 , 1550 , 1551 , 1552 , 1553 , 1554 , 1555 , 1556 , 1557 , 1558 , 1559 , 1560 , 1561 , 1562 , 1563 , 1564 , 1565 , 1566 , 1567 , 1568 , 1569 , 1570 , 1571 , 1572 , 1573 , 1574 , 1575 , 1576 , 1577 , 1578 , 1579 , 1580 , 1581 , 1582 , 1583 , 1584 , 1585 , 1586 , 1588 , 1589 , 1590 , 1591 , 1592 , 1593 , 1594 , 1595 , 1596 , 1597 , 1598 , 1599 , 1600 , 1601 , 1602 , 1603 , 1604 , 1605 , 1606 , 1607 , 1608 , 1609 , 1610 , 1611 , 1612 , 1613 , 1614 , 1615 , 1616 , 1617 , 1618 , 1619 , 1620 , 1621 , 1622 , 1623 , 1624 , 1625 , 1626 , 1627 , 1628 , 1629 , 1630 , 1631 , 1632 , 1633 , 1634 , 1635 , 1636 , 1637 , 1638 , 1639 , 1640 , 1641 , 1642 , 1643 , 1644 , 1645 , 1646 , 1647 , 1648 , 1649 , 1650 , 1651 , 1652 , 1653 , 1654 , 1655 , 1656 , 1657 , 1658 , 1659 , 1660 , 1661 , 1662 , 1663 , 1664 , 1665 , 1666 , 1667 , 1668 , 1669 , 1670 , 1671 , 1672 , 1673 , 1674 , 1675 , 1676 , 1677 , 1678 , 1679 , 1680 , 1681 , 1682 , 1683 , 1684 , 1685 , 1686 , 1687 , 1688 , 1689 , 1690 , 1691 , 1692 , 1693 , 1694 , 1695 , 1696 , 1697 , 1698 , 1699 , 1700 , 1701 , 1702 , 1703 , 1704 , 1705 , 1706 , 1707 , 1708 , 1709 , 1710 , 1711 , 1712 , 1713 , 1714 , 1715 , 1716 , 1717 , 1718 , 1719 , 1720 , 1721 , 1722 , 1723 , 1724 , 1725 , 202703 , 4439 , 49161 , 56173 , 6162 , 701158475 , 7162 , 71622 , 73361 , 7441 , 7502 , D614 .

Why it was recalled

The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.

Root cause (FDA determination)

Component design/selection

Action the firm took

Customers were contacted by a service organization that performed product inspections at their sites.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 2501 Barrington Rd, Hoffman Estates, Illinois 60195-2061

Distribution

Distribution pattern: Worldwide Distribution - US: Nationwide, including Washington D.C., and Puerto Rico. and the countries of: Poland, France, Austria, Czech Republic, Ireland, Germany, Italy, Japan, Canada, United Arab Emirates, Turkey, Netherlands, United Kingdom, Brazil, South Africa, Kuwait, Belgium, Russia, Taiwan, Australia, Bangladesh, Bulgaria, Brazil, Switzerland, Chile, China, Colombia, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, Hong Kong, Croatia, Hungary, Indonesia, Iran, Israel, India, South Korea, Kuwait, Kazakhstan, Lithuania, Latvia, Morocco, Mexico, Norway, New Zealand, Peru, Phillipines, Pakistan, Portugal, Qatar, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Taiwan, Venezuela, and Vietnam.

Timeline

Recall initiated: 2013-08-16
Terminated: 2016-12-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122573. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.