Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.
Enforcement
- Recall Number
- Z-0115-2015
- Event ID
- 66778
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 29, 2014
- Initiation Date
- October 28, 2013
- Classification Date
- October 22, 2014
- Termination Date
- December 23, 2016
- Address
- 2501 Barrington Rd, Hoffman Estates, IL, 60195-2061, United States
Description
Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.
Reports of loose bolts in the detector support structure of Symbia and E.CAM systems.
*** 1) Part Number 10275879; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 , 1015 , 1016 , 1017 , 1018 , 1019 , 1020 , 1021 , 1022 , 1023 , 1024 , 1025 , 1026 , 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 , 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 , 1361 , 1362 , 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 , 1506 , 1507 , 1508 , 1509 , 1510 , 1511 , 1512 , 1513 , 1514 , 1515 , 1516 , 1517 , 1519 , 700933850 ; *** 2) Part Number 10413009; Serial Numbers: 1001 , 1002 , 1003 , 1004 , 1005 , 1006 , 1007 , 1008 , 1009 , 1010 , 1011 , 1012 , 1013 , 1014 , 1015 , 1017 , 1018 , 1019 , 1020 , 1021 , 1022 , 1023 , 1024 , 1025 , 1026 , 1027 , 1028 , 1029 , 1030 , 1031 , 1032 , 1033 , 1034 , 1035 , 1036 , 1037 , 1038 , 1039 , 1040 , 1041 , 1042 , 1043 , 1044 , 1045 , 1046
Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the District of Columbia, Guam, and Puerto Rico; and, the countries of Albania, Algeria, Angola, Argentina, Austria, Australia, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cameroon, Canada, Chile, China, Columbia, Congo, Costa Rica, Cuba, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Luxembourg, Macedonia, Madagascar, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, and Yemen.
562 devices