Device product
BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 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-2016-2016
Product summary
- Event
- Event 74192
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2016-2016
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: 1001,1004,1015,1020,1024,1035,1042,44889,44977,45502,45509,45516,45518,45520,45522,45525,45527,45528,45532,45533,45539,45544,45547,45549,45554,45556,45560,45564,45574,45586,45587,45590,45600,45612,45615,45656,45660
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.