Device product
BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 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-2020-2016
Product summary
- Event
- Event 74192
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 units
- Official record key
device-enforcement:Z-2020-2016
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: 11001,11002,11003,11004,11005,11006,11007,11009,59001
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.