FDA-Device2016-06-29Class II
BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 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.
Siemens Medical Solutions USA Inc.
Hazard
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Sold states
Worldwide Distribution - US Nationwide
Affected count
2 units
Manufactured in
810 Innovation Dr, N/A, Knoxville, TN, United States
Products
BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2019-2016Don't want to check this manually?
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