CLASS II Device recall · Reported 19 Oct 2016 · FDA Enforcement Report
Symbia T Series Spect + CT recalled by Siemens Medical Solutions USA
Siemens Medical Solutions USA is recalling Symbia T Series Spect + CT, distributed nationwide in the US. The recall was initiated on 16 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0062-2017
- FDA event ID
- 66544
- Recalling firm
- Siemens Medical Solutions USA, Hoffman Estates, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Aug 2013
- FDA classified
- 7 Oct 2016
- Reported
- 19 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 16 Aug 2013 | Recall initiated by company | |
| 7 Oct 2016 | Classified by FDA | +1148 days |
| 19 Oct 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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 .
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 66544This product is part of a recall event; the main page for the event is Symbia S recalled by Siemens Medical Solutions USA.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Symbia S recalled by Siemens Medical Solutions USA | Siemens Medical Solutions USA | Other | Nationwide |
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