Siemens Medical Solutions USA Inc. recalls Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-R

Recalled June 29, 2016 · FDA recall Z-2017-2016 · 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

2 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 Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 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 →