Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by c…

Recall date

November 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0744-2017

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

Software update that provides software and firmware bug-fixes to improve system performance

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SOMATOM Definition Edge System, x-ray, tomography, computed 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