Symbia S-Series and Symbia T-Series - Product Usage recall
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…
Why was Symbia S-Series and Symbia T-Series - Product Usage recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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…
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 412 units
- Distribution
- 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.
- Recall date
- September 9, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)