Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls Cios Alpha, mobile X-ray system

Recall date
February 19, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1278-2016
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
Nationwide Distribution to the states of : AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA and WI

Why it was recalled

Software issues on Cios Alpha mobile C-Arm system

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

What was recalled

Cios Alpha, mobile X-ray system

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