Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls Axiom Artis fluoroscopic x-ray system

Recall date
February 27, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1468-2017
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
Distributed Nationwide

Why it was recalled

A gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.

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

What was recalled

Axiom Artis fluoroscopic x-ray system

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