Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls Artis zeego, Model Number 10280959

Recall date
June 12, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2034-2019
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

Artis zeego, Model Number 10280959

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