Siemens Medical Solutions USA, Inc recalls ARTIS Q, Interventional Fluroscopic x-ray system

Recall date

February 22, 2017

Source

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

Recall number

Z-1534-2017

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Distributed throughout the United States.

Why it was recalled

In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ARTIS Q, Interventional Fluroscopic x-ray system