Medical device recalls Moderate risk

GE Inspection Technologies, LP recalls GE Inspection Technologies Blade|line Industrial Cabinet X-ray system

Recall date
June 28, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2777-2017
FDA classification
Class II
Brand / firm
GE Inspection Technologies, LP
Sold / distributed
US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore

Why it was recalled

GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one hour (21 CFR ¿ 1020.40(c)(1)(i)) underneath the bottom center of the system. The crawl space affected by the excess emission is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed.

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 Blade|line Industrial Cabinet X-ray system

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