Medical device recalls Moderate risk

GE Inspection Technologies, LP recalls GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.

Recall date
December 16, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1231-2016
FDA classification
Class II
Brand / firm
GE Inspection Technologies, LP
Sold / distributed
US Distribution to the states of : TX, MD, MI, CA, TN, NH, NY, AL, NC, ID, MA, AZ, IN, FL, PA, NJ, WI, VA, MN, MD CO, GA, SC, OH and DC.

Why it was recalled

GE Inspection Technologies, LP ("GE") has discovered that certain of its cabinet x-ray systems may not fully comply with the Food and Drug Administration's (FDA) Cabinet X¿ ray System performance standards, 21 C.F.R. ¿ 1020.40(c)(1)(i)

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

What was recalled

GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.

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