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Siemens Medical Solutions USA Inc. recalls BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tom
Recalled June 29, 2016 · FDA recall Z-2012-2016 · Siemens Medical Solutions USA
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. · FDA Class II
Units
102 units
Sold at
Worldwide Distribution - US Nationwide
Description
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Product
BIOGRAPH 6 TruePoint, Material Number 10097289 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.
Manufacturer(s)
Siemens Medical Solutions USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →