Symbia T Series SPECT + CT 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.
Enforcement
- Recall Number
- Z-0062-2017
- Event ID
- 66544
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Other
- Report Date
- October 19, 2016
- Initiation Date
- August 16, 2013
- Classification Date
- October 7, 2016
- Termination Date
- December 23, 2016
- Address
- 2501 Barrington Rd, N/A, Hoffman Estates, IL, 60195-2061, United States
Description
Symbia T Series SPECT + CT 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.
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.
Material Number 10275007, Serial Numbers 1001 , 1006 , 1007 , 1032 , 1053 , 1104 , 1134 , 1012 , 1226 , 1014 , 1015 , 1284 , 1024 , 1034 , 1055 , 1060 , 1064 , 1038 , 1039 , 1065 , 1041 , 1071 , 1043 , 1044 , 1076 , 1098 , 1108 , 1109 , 1110 , 1050 , 1051 , 1111 , 1112 , 1113 , 1117 , 1056 , 1057 , 1119 , 1131 , 1137 , 1145 , 1146 , 1147 , 1160 , 1170 , 1066 , 1180 , 1181 , 1183 , 1189 , 1191 , 1199 , 1204 , 1074 , 1213 , 1215 , 1231 , 1232 , 1249 , 1252 , 1269 , 1287 , 1292 , 1318 , 1324 , 1086 , 1087 , 1325 , 1326 , 1090 , 1091 , 1327 , 1099 , 1101 , 1102 , 1116 , 1130 , 1042 , 1096 , 1097 , 1115 , 1173 , 1162 , 1235 , 1259 , 1309 , 1171 , 1175 , 1176 , 1178 , 1179 , 1185 , 1186 , 1036 , 1200 , 1202 , 1206 , 1209 , 1210 , 1211 , 1018 , 1026 , 1045 , 1216 , 1217 , 1058 , 1114 , 1128 , 1192 , 1193 , 1194 , 1195 , 1246 , 1257 , 1258 , 1291 , 1229 , 1307 , 1315 , 1234 , 1236 , 1242 , 1253 , 1262 , 1266 , 1267 , 1273 , 1276 , 1278 , 1282 , 1290 , 1295 , 1296 , 1310 , 1317 , 1319 , 1321 , 1322 , 1100 , 1208 , 1281 , 1062 , 1078 , 1009 , 1122 , 1132 , 1011 , 1017 , 1019 , 1077 , 1094 , 1106 , 1149 , 1168 , 1172 , 1221 , 1225 , 1251 , 1268 , 1305 , 1142 , 1254 , 1320 , 1247 , 1264 , 1285 , 1299 , 1125 , 1143 , 1190 , 1277 , 1005 , 1008 , 1021 , 1047 , 1049 , 1070 , 1073 , 1075 , 1105 , 1107 , 1124 , 1144 , 1150 , 1158 , 1163 , 1164 , 1165 , 1177 , 1182 , 1184 , 1188 , 1196 , 1197 , 1203 , 1214 , 1218 , 1219 , 1239 , 1244 , 1250 , 1263 , 1265 , 1271 , 1279 , 1288 , 1303 , 1306 , 1312 , 1313 , 1029 , 1030 , 1035 , 1046 , 1079 , 1085 , 1156 , 1159 , 1207 , 1224 , 1261 , 1272 , 1283 , 1151 , 1152 , 1153 , 1154 , 1169 , 1227 , 1311 , 1088 , 1135 , 1166 , 1238 , 1297 , 1010 , 1031 , 1120 , 1121 , 1123 , 1013 , 1061 , 1069 , 1083 , 1103 , 1167 , 1187 , 1223 , 1294 , 1016 , 1020 , 1025 , 1027 , 1054 , 1067 , 1068 , 1080 , 1081 , 1082 , 1089 , 1129 , 1161 , 1201 , 1205 , 1228 , 1230 , 1233 , 1240 , 1245 , 1286 , 1298 , 1300 , 1302 , 1304 , 1157 , 1040 , 1275 , 1023 , 1033 , 1092 , 1118 , 1139 , 1140 , 1141 , 1155 , 1212 , 1220 , 1222 , 1243 , 1255 , 1256 , 1270 , 1308 , 1260 , 1003 , 1028 , 1095 , 1241 , 1293 , 1314 , 1048 , 1063 , 1136 , 1289 , 1138 , 1198 , 1248 , 1148 , 1072 , 1127 , 1022 , 1323 , 1052 , 1084 , 1126 , 1301 , 1037 , 1059 , 1093 , 1133 , 1174 , 1237 , 1274 , 1316 , 46114 , 6053 , 68282 , 74401 , 74404 , 8473047245. Material Number 10275008, Serial Numbers 1071 , 1077 , 1051 , 1063 , 1124 , 1054 , 1172 , 1016 , 1032 , 1033 , 1060 , 1093 , 1171 , 1045 , 1049 , 1056 , 1082 , 1092 , 1095 , 1107 , 1111 , 1121 , 1123 , 1131 , 1138 , 1144 , 1145 , 1176 , 1182 , 1098 , 1002 , 1068 , 1166 , 1009 , 1035 , 1011 , 1037 , 1044 , 1059 , 1074 , 1083 , 1102 , 1103 , 1118 , 1141 , 1142 , 1149 , 1023 , 1156 , 1161 , 1170 , 1028 , 1029 , 1173 , 1178 , 1181 , 1186 , 1038 , 1040 , 1058 , 1090 , 1091 , 1094 , 1053 , 1097 , 1062 , 1099 , 1100 , 1104 , 1108 , 1113 , 1114 , 1117 , 1139 , 1150 , 1177 , 1165 , 1167 , 1168 , 1169 , 1179 , 1180 , 1184 , 1185 , 1566 , 1039 , 1042 , 1055 , 1065 , 1066 , 1096 , 1109 , 1127 , 1128 , 1153 , 1175 , 1003 , 1057 , 1080 , 1001 , 1004 , 1006 , 1007 , 1012 , 1013 , 1021 , 1024 , 1026 , 1036 , 1048 , 1052 , 1061 , 1070 , 1084 , 1087 , 1101 , 1105 , 1106 , 1135 , 1158 , 1010 , 1030 , 1031 , 1078 , 1143 , 1018 , 1020 , 1183 , 1120 , 1140 , 1017 , 1025 , 1064 , 1089 , 1188 , 1022 , 1047 , 1067 , 1075 , 1086 , 1116 , 1125 , 1126 , 1132 , 1136 , 1137 , 1151 , 1041 , 1085 , 1147 , 1008 , 1069 , 1115 , 1133 , 1160 , 1162 , 1164 , 1110 , 1073 , 1159 , 1088 , 1154 , 1076 , 1014 , 1015 , 1134 , 1072 , 1119 , 1122 , 1130 , 1146 , 1155 , 1174 , 1050 , 1079 , 1148 , 1081 , 1005 , 1157 , 1046 , 1019 , 1034 , 1129 , 1152 , 17283 , 17440 , 62322 , 7283 , 72836 , 72837 , 72862 , 7440 , 74409 , 7444 , 8473047245. Material Number 10275009, Serial Numbers 1140 , 1006 , 1044 , 1046 , 1089 , 1153 , 1195 , 1009 , 1014 , 1072 , 1090 , 1100 , 1132 , 1155 , 1178 , 1182 , 1041 , 1124 , 1024 , 1026 , 1069 , 1076 , 1091 , 1104 , 1120 , 1127 , 1145 , 1159 , 1123 , 1128 , 1033 , 1102 , 1106 , 1110 , 1156 , 1165 , 1187 , 1193 , 1194 , 1114 , 1086 , 1051 , 1080 , 1092 , 1149 , 1066 , 1001 , 1007 , 1008 , 1047 , 1060 , 1011 , 1013 , 1015 , 1017 , 1019 , 1022 , 1025 , 1027 , 1028 , 1029 , 1030 , 1034 , 1040 , 1093 , 1131 , 1133 , 1052 , 1056 , 1057 , 1064 , 1071 , 1077 , 1078 , 1082 , 1083 , 1084 , 1088 , 1094 , 1095 , 1098 , 1099 , 1101 , 1105 , 1108 , 1111 , 1036 , 1129 , 1079 , 1085 , 1103 , 1112 , 1134 , 1135 , 1115 , 1126 , 1139 , 1166 , 1168 , 1142 , 1170 , 1144 , 1173 , 1146 , 1179 , 1151 , 1152 , 1157 , 1158 , 1160 , 1161 , 1162 , 1164 , 1174 , 1180 , 1183 , 1184 , 1186 , 1190 , 1196 , 1012 , 1050 , 1068 , 1070 , 1109 , 1143 , 1004 , 1075 , 1031 , 1038 , 1065 , 1119 , 1167 , 1192 , 1113 , 1010 , 1016 , 1018 , 1020 , 1021 , 1023 , 1039 , 1042 , 1048 , 1063 , 1074 , 1081 , 1097 , 1117 , 1125 , 1148 , 1154 , 1163 , 1175 , 1191 , 1058 , 1141 , 1130 , 1172 , 1087 , 1107 , 1121 , 1122 , 1037 , 1053 , 1062 , 1137 , 1005 , 1043 , 1045 , 1061 , 1067 , 1138 , 1176 , 1032 , 1059 , 1150 , 1054 , 1116 , 1118 , 1147 , 1171 , 1185 , 1002 , 1055 , 1049 , 1177 , 1073 , 1181 , 1003 , 1035 , 1096 , 1169 , 1197 , 62323 , 7440 , 7502. Material Number 10275010, Serial Numbers 1161 , 1163 , 1059 , 1072 , 1006 , 1053 , 1061 , 1076 , 1078 , 1096 , 1108 , 1109 , 1113 , 1116 , 1117 , 1118 , 1119 , 1141 , 1142 , 1153 , 1160 , 1166 , 1173 , 1030 , 1049 , 1145 , 1150 , 1057 , 1058 , 1156 , 1012 , 1052 , 1149 , 1151 , 1005 , 1014 , 1079 , 1122 , 1168 , 1037 , 1045 , 1056 , 1066 , 1088 , 1121 , 1136 , 1155 , 1167 , 1125 , 1019 , 1022 , 1034 , 1044 , 1048 , 1050 , 1093 , 1101 , 1107 , 1112 , 1135 , 1064 , 1111 , 1120 , 1172 , 1103 , 1140 , 1152 , 1171 , 1001 , 1003 , 1004 , 1008 , 1009 , 1011 , 1013 , 1015 , 1016 , 1017 , 1018 , 1025 , 1027 , 1028 , 1031 , 1032 , 1038 , 1039 , 1042 , 1043 , 1051 , 1054 , 1055 , 1070 , 1071 , 1075 , 1002 , 1021 , 1026 , 1047 , 1085 , 1083 , 1084 , 1095 , 1086 , 1154 , 1089 , 1090 , 1094 , 1097 , 1098 , 1100 , 1102 , 1104 , 1105 , 1110 , 1115 , 1130 , 1137 , 1138 , 1139 , 1143 , 1164 , 1158 , 1170 , 1007 , 1024 , 1040 , 1065 , 1074 , 1082 , 1087 , 1091 , 1092 , 1133 , 1144 , 1147 , 1148 , 1162 , 1165 , 1174 , 1146 , 1035 , 1077 , 1134 , 1029 , 1036 , 1041 , 1063 , 1069 , 1080 , 1081 , 1114 , 1159 , 1010 , 1067 , 1124 , 1033 , 1129 , 1062 , 1073 , 1106 , 1126 , 1127 , 1128 , 1131 , 1132 , 1046 , 1020 , 1023 , 1157 , 1068 , 1060 , 1099 , 1123 , 1644 , 268045 , 72838 , 74401 . Material Number 8717733, Serial Numbers 1040 , 1088 , 1103 , 1157 , 1158 , 1159 , 1163 , 1041 , 1042 , 1043 , 1071 , 1072 , 1073 , 1074 , 1083 , 1090 , 1107 , 1147 , 1171 , 1173 , 1178 , 1196 , 1197 , 1009 , 1038 , 1066 , 1068 , 1070 , 1076 , 1079 , 1087 , 1128 , 1143 , 1144 , 1150 , 1153 , 1177 , 1188 , 1189 , 1193 , 1199 , 1108 , 1194 , 1000 , 1005 , 1057 , 1061 , 1094 , 1116 , 1141 , 1151 , 1183 , 1205 , 1025 , 1101 , 1024 , 1029 , 1044 , 1048 , 1053 , 1062 , 1081 , 1086 , 1106 , 1117 , 1135 , 1181 , 1209 , 701001 , 1058 , 1082 , 1105 , 1162 , 1064 , 1010 , 1015 , 1032 , 1050 , 1119 , 1013 , 1014 , 1016 , 1017 , 1027 , 1035 , 1036 , 1039 , 1051 , 1060 , 1078 , 1084 , 1085 , 1099 , 1109 , 1110 , 1111 , 1112 , 1122 , 1129 , 1132 , 1136 , 1140 , 1145 , 1155 , 1156 , 1164 , 1165 , 1166 , 1172 , 1186 , 1192 , 1195 , 1201 , 1120 , 1137 , 1146 , 1148 , 1149 , 1176 , 1185 , 1045 , 1095 , 1097 , 1004 , 1007 , 1008 , 1011 , 1019 , 1020 , 1021 , 1022 , 1023 , 1026 , 1028 , 1056 , 1059 , 1098 , 1034 , 1121 , 1200 , 1037 , 1052 , 1054 , 1055 , 1065 , 1067 , 1075 , 1077 , 1080 , 1091 , 1093 , 1113 , 1115 , 1118 , 1125 , 1126 , 1133 , 1139 , 1142 , 1089 , 1124 , 1130 , 1134 , 1160 , 1152 , 1154 , 1161 , 1167 , 1168 , 1169 , 1170 , 1175 , 1180 , 1182 , 1187 , 1191 , 1198 , 1202 , 1203 , 1204 , 1206 , 1208 , 1092 , 1012 , 1049 , 1096 , 1063 , 1033 , 1100 , 1174 , 1030 , 1127 , 1138 , 1184 , 1003 , 1104 , 1179 , 1190 , 1046 , 1001 , 1002 , 1006 , 1018 , 1031 , 1102 , 1114 , 1131 , 1210 , 733612 , D613 .
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.
1109 units