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U.S. Department of Health and Human Services

Class 2 Device Recall EVO Excel

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 Class 2 Device Recall EVO Excelsee related information
Date Initiated by FirmOctober 05, 2018
Create DateNovember 02, 2018
Recall Status1 Terminated 3 on February 11, 2021
Recall NumberZ-0372-2019
Recall Event ID 80927
510(K)NumberK162337 
Product Classification System, tomography, computed, emission - Product Code KPS
ProductEVO Excel, Emission Computed Tomographic System, Material Number 10910501
Code Information Serial Numbers:  1001 1002 1003 1004 1005 1006 1007 1008 1009 1010 1011 1012 1013 1014 1015 1016 1017 1018 1019 1020 1021 1022 1023 1024 1025 1026 1027 1028 1029 1030 1031 1032 1033 1034 1035 1036 1037 1038 1039 1040 1041 1042 1043 1044 1045 1046 1047 1048 1049 1050 1051 1052 1053 1054 1055 1056 1057 1058 1059 1060 1061 1062 1063 1064 1065 1066 1067 1068 1069 1072 1073 1074 1075 1076 1077 1078 1079 1080 1081 1082 1083 1084 1085 1086 1087 1088 1089 1090 1091 1092 1093 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 1120 1121 1122 1123 1124 1125 1126 1127 1128 1129 1130 1131 1132 1133 1134 1135 1137 1138 1139 1140 1141 1142 1144 1145 1146 1147 1148 1150 1151 1152 1153 1154 1155 1156 1157 1158 1159 1160 1161 1162 1163 1164 1165 1166 1168 1169 1170 1171 1172 1173 1174 1175 1176 1177 1178 1179 1181 1182 1183 1185 1186 1187 1188 1189 1190 1191 1192 1193 1194 1195 1196 1197 1198 1199 1200 1201 1203 1204 1205 1206 1207 1210 1211 1212 1213 1214 1215 1216 1217 1218 1219 1220 1221 1222 1223 1225 1226 1227 1228 1229 1230 1231 1232 1233 1234 1235 1236 1237 1238 1239 1240 1241 1242 1243 1244 1245 1246 1250 1251 1252 1253 1255 1256 1257 1258 1259 1260 1261 1262 1263 1264 1265 1266 1267 1268 1269 1270 1272 1273 1274 1276 1279 1280 1283 1287 1288 1289 
FEI Number 1000514697
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
2501 Barrington Rd
Hoffman Estates IL 60192-2061
For Additional Information ContactLaura Meyer
847-217-2734
Manufacturer Reason
for Recall		The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be labeled 0.55A.,
FDA Determined
Cause 2		Other
ActionSiemens disseminated the notices by letter on 10/05/2018. Firm will deliver a Symbia Evo Excel Addendum and DVD addendum with this updated information at a later date.
Quantity in Commerce264 units
DistributionWorldwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KPS
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