Siemens Medical Solutions USA, Inc recalls SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by…

Recall date

April 1, 2016

Source

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

Recall number

Z-1558-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide Distribution : NC, NH, IL, MA, WA, PA, MD, MN, TX, NY, SC, OH, CA, KY, MT, IA

Why it was recalled

The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to a misdiagnosis (i.e. either non-existing blood or liquid is mimicked in the images or actual existing blood or liquid is not depicted as expected). There is also a risk of a potential misdiagnosis in using this protocol for surgery planning. Investigations revealed an incorrect parameterization of the reconstruction algorithm applied for the pediatric head kernel as cause of the problem.

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, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.