Class 2 Device Recall Symbia S

• Date Initiated by Firm: August 16, 2013
• Create Date: October 08, 2016
• Recall Status: Terminated on December 23, 2016
• Recall Number: Z-0061-2017
• Recall Event ID: 66544
• 510(K)Number: K041166
• Product Classification: System, tomography, computed, emission - Product Code KPS
• 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. .
• Code Information: 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 .
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 2501 Barrington Rd; Hoffman Estates IL 60195-2061
• For Additional Information Contact: 847-304-7700
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Component design/selection
• Action: Customers were contacted by a service organization that performed product inspections at their sites.
• Quantity in Commerce: 732 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPS