Medical device recalls Moderate risk

Xoran Technologies, LLC recalls Xoran MiniCAT X-ray imaging device

Recall date
September 8, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1210-2015
FDA classification
Class II
Brand / firm
Xoran Technologies, LLC
Sold / distributed
Nationwide Distribution

Why it was recalled

Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose.

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

What was recalled

Xoran MiniCAT X-ray imaging device

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