FDA-Device2016-04-13Class II

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

GE Inspection Technologies, LP
Hazard

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)

Sold states
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.
Affected count
55 US Distribution
Manufactured in
50 Industrial Park Rd, N/A, Lewistown, PA, United States
Products
GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1231-2016

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