Device product
Biograph mCT-X 3R, MATERIAL NUMBER 10248673 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-2034-2016
Product summary
- Event
- Event 74192
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22 units
- Official record key
device-enforcement:Z-2034-2016
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: 1002,1003,1004,1005,1006,1007,11009,11010,11011,11012,11008,11013,11015,11019,11017,11018,11020,31021,31022,31023,11014,1001
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.