Medical device recalls Moderate risk

North Star Imaging Inc recalls North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware

Recall date
August 23, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0063-2018
FDA classification
Class II
Brand / firm
North Star Imaging Inc
Sold / distributed
US Distribution to the states of : PA, OH and KS.

Why it was recalled

It was discovered a low-level radiation leak that was found on the NSI X-7000 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

North Star Imaging Inc. (NSI) Model X-7000 industrial cabinet x-ray system. Industrial x-ray imaging of product hardware

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