Siemens Medical Solutions USA, Inc recalls AXIOM Artis BA, Model Number 5904656

Recall date

June 12, 2019

Source

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

Recall number

Z-2016-2019

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

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 BA, Model Number 5904656