FDA-Device2016-11-23Class II
SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles
Siemens Medical Solutions USA, Inc
Hazard
Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care Contrast license correction of potential safety issues.
Sold states
Nationwide distribution to MI, NY, CA, KY, ND, and NE.
Affected count
7 systems
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0606-2017Don't want to check this manually?
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