Device product
BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Z-2015-2016
Product summary
- Event
- Event 74192
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 units
- Official record key
device-enforcement:Z-2015-2016
Official wording
Reason: Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Code information: Serial Numbers: 1002,1003,1004,1005,1006,1007,1008,1011,1013,1014,1015,1016,1017,1019,1020,1021,1022,1023,1024,1025,1028,1029,1030,1031,1032,1033,1034,1036,1037,1038,1039,1041,1042,1043,1045,1046,1048,1049,1050,1051,1052,1054,1055,11057,11059,11060,11061,11063,58004
Distribution pattern: Worldwide Distribution - US Nationwide
Derived failure modes
-
Unknown
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.