Siemens Medical Solutions USA, Inc recalls SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer rec…

Recall date

December 3, 2014

Source

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

Recall number

Z-0971-2015

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

PA, MA, MN, SC, MD, and TX.

Why it was recalled

Artifacts are found in acquired imaging on the SOMATOM Force.

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 Force; the intended use of computed tomography is 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 angels or spiral planes taken at different angles.