The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
Enforcement
- Recall Number
- Z-1086-2015
- Event ID
- 70259
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Other
- Report Date
- February 18, 2015
- Initiation Date
- October 23, 2012
- Classification Date
- February 10, 2015
- Termination Date
- December 23, 2016
- Address
- 2501 Barrington Rd, N/A, Hoffman Estates, IL, 60195-2061, United States
Description
The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
1) Symbia S; Materal 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 , 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 , 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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 , 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1715 , 1716 , 1717 , 1718 , 1719 , 1720 , 1721 , 1722 , 1723 , 1724 , 1725 , 701158475
Worldwide Distribution-US (nationwide) including DC and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, and WY), and the countries of AUSTRALIA , AUSTRIA, BANGLADESH , BELGIUM , BRAZIL , BULGARIA , CANADA , CHILE , CHINA , COLOMBIA , CROATIA , CZECH REPUBLIC , DENMARK , ECUADOR , EGYPT , FINLAND , FRANCE , GERMANY , GREECE , HONG KONG , HUNGARY , INDIA , INDONESIA , IRAN , IRELAND , ISRAEL , ITALY , JAPAN , KUWAIT , LATVIA , LITHUANIA , MEXICO , MOROCCO , NETHERLANDS , NEW ZEALAND , NORWAY , PERU , PHILIPPINES , POLAND , PORTUGAL , QATAR , ROMANIA , RUSSIA , SAUDI ARABIA , SINGAPORE , SLOVAKIA , SOUTH AFRICA , SPAIN , SWEDEN , SWITZERLAND , TAIWAIN , THAILAND , TUNISIA , TURKEY , UNITED ARAB EMIRATES, UNITED KINGDOM , and VENEZUELA.
719 systems (global)