Device product
BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 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-2014-2016
Product summary
- Event
- Event 74192
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 units
- Official record key
device-enforcement:Z-2014-2016
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: 1021,1024,1027,1029,1030,1031,1032,1033,1034,1037,11044,11045,11046,11047,11048,11049
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.