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Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are intended to pr
Recalled November 23, 2016 · FDA recall Z-0605-2017 · Siemens Medical Solutions USA
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. · FDA Class II
Units
3077 systems worldwide, 760 systems distributed in the U.S.
Sold at
US Nationwide Distribution
Description
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.
Product
SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS 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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →