FDA Device recall Z-0062-2017
Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the fol…
- FDA Device
- Class II
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class II recall of Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the fol… by Siemens Medical Solutions Usa, citing 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 bear….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0062-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-16 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Material Number 10275007, Serial Numbers 1001 , 1006 , 1007 , 1032 , 1053 , 1104 , 1134 , 1012 , 1226 , 1014 ,…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 , |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0062-2017%22
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