Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and proc…

Recall date

February 14, 2019

Source

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

Recall number

Z-1245-2019

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.

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, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.