FDAFDA · Alimentos y medicamentos·N.º oficial Z-2934-2020
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.
Publicado el 9 de septiembre de 2020 · Inicio del retiro: 14 de agosto de 2020
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Siemens Medical Solutions USA, Inc.
- Distribuidor
- 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.
- Lote
- 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.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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