FDA-Device2016-11-23Class II
SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash 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
A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out. There is a risk that a person could touch rotating or electrical parts of the gantry if they were to reach through the window opening.
Sold states
US Nationwide Distribution
Affected count
762 systems distrtibuted in U.S.
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash 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-0604-2017Don't want to check this manually?
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