Siemens Medical Solutions USA, Inc recalls SOMATOM Definition AS (Model 8098027) Computed tomography x-ray diagnostic system

Recall date

November 8, 2017

Source

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

Recall number

Z-1745-2018

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico.

Why it was recalled

There is a potential risk of unnecessary radiation exposure due to a software issue found in the CARE Dose4D algorithm implemented in Siemens Healthineers CT scanners of types SOMATOM Definition AS, SOMATOM Definition DS, SOMATOM Definition Edge, SOMATOM Definition Flash and 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 Definition AS (Model 8098027) Computed tomography x-ray diagnostic system