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Z-2934-2020 Class II Terminated

Recalled by Siemens Medical Solutions USA, Inc. — Hoffman Estates, IL

FDA device recall Z-2934-2020 was initiated by Siemens Medical Solutions USA, Inc. on August 14, 2020 and is designated Class II. Reason for recall: This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential risk. The recall status is terminated (terminated May 1, 2023). Affected quantity: 412 units.

Recall Details

Product Type: Devices
Report Date: September 9, 2020
Initiation Date: August 14, 2020
Termination Date: May 1, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 412 units

Product Description

Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device 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 588keV.

Reason for Recall

This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential risk.

Distribution Pattern

US Nationwide distribution including in the states of Alabama, Alaska, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia and Wisconsin.

Code Information

Model:8717741, 8717733, 10275007, 10275008, 10275009, 10275010 Serial Numbers: 1054, 1075, 1124, 1019, 1235, 1230, 1002, 1019, 1105, 1135, 1217, 1158, 1026, 1037, 1081, 1128, 1165, ,1013, 1009, 1049, 1050, 1067, 1077, 1144, 1150, 1151, 1179, 1191, 1210, 1247, 1074, 1149, 1202, 1180, 1017, 1018, 1055, 1048, 1080, 1131, 1173, 1176, 1008, 1203, 1077, 1076, 1079, 1095, 1115, 1215, 1152, 1001, 1046, 1055, 1109, 1184, 1236, 1001, 1092, 1160, 1193, 1023, 1028, 1032, 1096, 1207, 1219, 1250, 1022, 1175, 1132, 1023, 1145, 1177, 1052, 1045, 1152, 1016, 1027, 1182, 1066, 1072, 1136, 1216, 1019, 1203, 1011, 1011, 1126, 1142, 1010, 1024, 1029, 1053, 1089, 1178, 1001, 1206, 1252, 1122, 1143, 1015, 1027, 1245, 1012, 1011, 1028, 1029, 1243, 1113, 1198, 1154, 1018, 1036, 1071, 1097, 1099, 1170, 1052, 1195, 1034, 1088, 1121, 1133, 1139, 1208, 1007, 1248, 1167, 1137, 1004, 1011, 1015, 1051, 1060, 1104, 1110, 1114, 1134, 1142, 1168, 1171, 1192, 1212, 1218, 1220, 1232, 1240, 1241, 1242, 1029, 1148, 1229, 1231, 1067, 1082, 1249, 1030, 1037, 1065, 1017, 1033, 1064, 1108, 1125, 1183, 1194, 1196, 1205, 1080, 1169, 1170, 1041, 1093, 1118, 1139, 1161, 1201, 1025, 1084, 1120, 1174, 1020, 1191, 1003, 1005, 1006, 1073, 1094, 1123, 1126, 1222, 1225, 1233, 1002, 1208, 1100, 1013, 1014, 1083, 1118, 1119, 1129, 1162, 1163, 1204, 1007, 1138, 1186, 1133, 1091, 1014, 1182, 1039, 1057, 1065, 1197, 1024.