Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray tra…

Recall date

August 14, 2015

Source

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

Recall number

Z-0019-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Nationwide Distribution.

Why it was recalled

software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin

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; 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.