Siemens Medical Solutions USA, Inc recalls SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data fr…

Recall date

June 4, 2015

Source

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

Recall number

Z-1933-2015

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Nationwide Distribution.

Why it was recalled

A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.

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 Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.