Device product
Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 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-2030-2016
Product summary
- Event
- Event 74192
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47 units
- Official record key
device-enforcement:Z-2030-2016
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: 1002,1004,1006,1007,1005,1010,1013,1016,1017,11018,11019,11031,1012,11020,1014,11026,11022, 1015,11024,11025,11023,11027,11028,11030,11032,11038,11033,11034,11036,11039,11037,11040, 11041,11044,11042,21045,21048,31047,31049,11029,1008,1009,1011,11021,11033,11035,31046
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.