Siemens Medical Solutions USA, Inc recalls SOMATOM Scope, Computed tomography x-ray system

Recall date

November 22, 2016

Source

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

Recall number

Z-0919-2017

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Distributed to: IL IL GA SC SD OK NY MI IN MD AR

Why it was recalled

Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.

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 Scope, Computed tomography x-ray system