—#132097

Product

Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K082506
Affected lot / code info: 1) Symbia T; Part Number: 10275007; Serial Numbers: 1055 , 1057 , 1058 , 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 , 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 , 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 , 1175 , 1176 , 1177 , 1178 , 1179 , 1180 , 1181 , 1182 , 1183 , 1184 , 1185 , 1186 , 1187 , 1188 , 1189 , 1190 , 1191 , 1193 , 1194 , 1195 , 1196 , 1197 , 1198 , 1199 , 1200 , 1201 , 1202 , 1203 , 1204 , 1205 , 1206 , 1207 , 1208 , 1209 , 1210 , 1211 , 1212 , 1214 , 1215 , 1216 , 1217 , 1218 , 1219 , 1220 , 1221 , 1222 , 1223 , 1224 , 1225 , 1226 , 1227 , 1228 , 1229 , 1230 , 1231 , 1232 , 1233 , 1234 , 1235 , 1236 , 1238 , 1239 , 1240 , 1241 , 1242 , 1243 , 1244 , 1245 , 1246 , 1247 , 1248 , 1250 , 1254 , 1266; 2) Symbia T2; Part Number 10275008; Serial Numbers: 1026 , 1028 , 1029 , 1035 , 1040 , 1044 , 1052 , 1054 , 1055 , 1056 , 1057 , 1058 , 1059 , 1060 , 1061 , 1062 , 1067 , 1071 , 1072 , 1073 , 1074 , 1075 , 1076 , 1077 , 1078 , 1079 , 1080 , 1081 , 1082 , 1083 , 1085 , 1086 , 1087 , 1088 , 1089 , 1090 , 1091 , 1092 , 1094 , 1095 , 1096 , 1097 , 1098 , 1099 , 1100 , 1101 , 1102 , 1103 , 1104 , 1107 , 1108 , 1109 , 1110 , 1111 , 1113 , 1114 , 1115 , 1116 , 1117 , 1118 , 1119 , 1120 , 1121 , 1122 , 1123 , 1125 , 1126 , 1127 , 1128 , 1129 , 1130 , 1131 , 1132 , 1133 , 1135 , 1136 , 1137 , 1138 , 1139 , 1140 , 1141 , 1142 , 1143 , 1144 , 1145 , 1147 , 1148 , 1149 , 1150 , 1151 , 1152 , 1153 , 1154 , 1156 , 1157 , 1158 , 1159 , 1160 , 1161 , 1162 , 1164 , 1166 , 1167 , 1168 , 1169 , 1566

Why it was recalled

There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.

Root cause (FDA determination)

Component change control

Action the firm took

The firm, Siemens, sent an undated "Customer Safety Advisory Notice" letter to all customers. The described the product, problem and actions to be taken. The letters inlcuded instructions for customers to: 1) continue to use their systems while waiting for the field correction to be scheduled and performed; 2) ensure that the safety advisory is placed in the system's instruction for use; and, 3) closely observe the patient during studies. The letter also instructs customers of record to forward a copy of the letter to the new owner if the equipment was sold or transferred. Customers with any questions about this issue can contact Siemens Molecular Imaging at 800-888-7436 (US).

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 Puerto Rico; Austria, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Great Britain, Hungary, Ireland, India, Iran, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, and Tunisia.

Timeline

Recall initiated: 2014-03-05
Posted by FDA: 2015-01-13
Terminated: 2016-12-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132097. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.