—#132644

Product

Symbia E is a multi-purpose SPECT system used 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.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072567
Affected lot / code info: 1) Symbia E Dual Head System; Material 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 , 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 , 14633 , 20448 , 49161 , 204481 , 491611 , 2005003 , 700933850 , D615 ; 2) Symbia E Single Head System; Material 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

Why it was recalled

Radial motor drives replaced during a customer service action were incorrectly assembled backwards.

Root cause (FDA determination)

Employee error

Action the firm took

Urgent Field Correction- Recall letters dated April 11, 2012 were sent to all potentially affected customers. The letters included instructions for customers to immediately remove the patient from the bed and contact the customer's Service Engineer in the event that one of the following errors is displayed "A motion control error has occurred (E112)" or "A motion control error has occurred (E113)." Customers were advised that a Service Engineer will be inspecting the radial drive gear on the customer's camera system to ensure it is functioning correctly and that the machines can continue to be used as usual until the Service Engineer can perform the inspection of the machine(s). Customers with questions were advised to contact Siemens as 800-888-7436.

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 the District of Columbia and the states of 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, VA, VT, WA, WI, and WV and the countries of AE, AL, AO, AR, AT, AU, BA, BD, BE, BG, BH, BO, BR, BW, BY, CA, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FA, FI, FR, GB, GE, GR, HK, HR, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KR, KW, KZ, LB, LK, LU, LV, MA, MK, MM, MU, MX, MY, NE, NG, NL, NO, NP, NZ, OM, PE, PH, PK, PL, PS, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, SV, SY, TH, TN, TR, TW, UA, UG, UY, UZ, VN, YE, and ZA.

Timeline

Recall initiated: 2012-04-11
Posted by FDA: 2015-03-19
Terminated: 2016-12-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132644. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.