Company: Siemens Medical Solutions USA, Inc.
Date of Enforcement Report 6/29/2016
Class lI:

PRODUCT
SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 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-2035-2016

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..

RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Knoxville, TN on 4/22/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4 units

DISTRIBUTION
Nationwide

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