Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 6/29/2016
BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529159 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.
Recall Number Z-2023-2016
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration..
Siemens Medical Solutions USA, Inc, Knoxville, TN on 4/22/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE