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Siemens Medical Solutions USA Inc. recalls Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appro
Recalled March 15, 2017 · FDA recall Z-1424-2017 · Siemens Medical Solutions USA
Hazard
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems. · FDA Class II
Units
9 units
Sold at
Worldwide distribution - US Nationwide in the states of CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY and the countries of Switzerland, Great Britain, Italy
Description
The mobile-specific instructions was not shipped to a limited population of Biograph Mobile systems.
Product
Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
Manufacturer(s)
Siemens Medical Solutions USA Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →