FDA-Device2017-08-09Class II
GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
GE Inspection Technologies, LP
Hazard
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.
Sold states
US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore
Affected count
13 units distributed in the US
Manufactured in
50 Industrial Park Rd, N/A, Lewistown, PA, United States
Products
GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2777-2017Don't want to check this manually?
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