GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
FDA Recall #Z-1231-2016 — Class II — December 16, 2015
Product Description
GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
Reason for Recall
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)
Recalling Firm
GE Inspection Technologies, LP — Lewistown, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
55 US Distribution
Distribution
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.
Code Information
phoenix micrornelx and nanomelx cabinet x-ray systems
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.