Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of rad...
FDA Device Recall #Z-0062-2017 — Class II — August 16, 2013
Recall Summary
| Recall Number | Z-0062-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 16, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Medical Solutions USA, Inc. |
| Location | Hoffman Estates, IL |
| Product Type | Devices |
| Quantity | 1109 units |
Product 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.
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.
Distribution Pattern
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.
Lot / Code Information
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 .
Other Recalls from Siemens Medical Solutions USA, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3217-2024 | Class II | ACUSON Maple 1.0 Diagnostic Ultrasound System, ... | Aug 15, 2024 |
| Z-3215-2024 | Class II | ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ul... | Aug 15, 2024 |
| Z-3216-2024 | Class II | ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasoun... | Aug 15, 2024 |
| Z-1599-2024 | Class II | ACUSON Juniper Diagnostic Ultrasound System, RE... | Feb 23, 2024 |
| Z-1601-2024 | Class II | ACUSON Maple Diagnostic Ultrasound System, REF:... | Feb 23, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.