FDA Device recall Z-0911-2015
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnos…
- FDA Device
- Class II
- terminated
- Published 2015-01-14
On 2015-01-14 the FDA classified a Class II recall of The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnos… by Siemens Medical Solutions Usa, citing siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0911-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-12 |
| Published | 2015-01-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: planar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588 keV. Software: The syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT, and other imaging modalities.
Reason
Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detectors. This unintended motion, should it occur, may cause the patient compression related injuries.
Identifiers
| code_info | 1) Symbia S; Product Number: 8717741; Serial Numbers: 1001 ; 1002 ; 1003 ; 1005 ; 1006 ; 1007 ; 1008 ; 1009 ; 1…1) Symbia S; Product Number: 8717741; Serial Numbers: 1001 ; 1002 ; 1003 ; 1005 ; 1006 ; 1007 ; 1008 ; 1009 ; 1010 ; 1011 ; 1012 ; 1013 ; 1014 ; 1015 ; 1016 ; 1017 ; 1018 ; 1019 ; 1020 ; 1021 ; 1022 ; 1023 ; 1024 ; 1025 ; 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 ; 1071 ; 1072 ; 1073 ; 1074 ; 1075 ; 1076 ; 1077 ; 1078 ; 1079 ; 1080 ; 1081 ; 1082 ; 1083 ; 1084 ; 1085 ; 1086 ; 1087 ; 1088 ; 1089 ; 1090 ; 1091 ; 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 ; 11 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0911-2015%22
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