Class 2 Device Recall Symbia T and Symbia T2

• Date Initiated by Firm: March 05, 2014
• Date Posted: January 13, 2015
• Recall Status: Terminated on December 23, 2016
• Recall Number: Z-0960-2015
• Recall Event ID: 69995
• 510(K)Number: K082506
• Product Classification: System, tomography, computed, emission - Product Code KPS
• Product: Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.
• Code Information: 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
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc.; 2501 Barrington Rd; Hoffman Estates IL 60195-2061
• For Additional Information Contact: 800-888-7436
• Manufacturer Reason for Recall: There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.
• FDA Determined Cause: Component change control
• Action: 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).
• Quantity in Commerce: 295 systems
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPS