FDAFDA · Food and drugs·Recall number Z-1231-2016
GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
Published April 13, 2016 · Recall initiated: December 16, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- GE Inspection Technologies, LP
- Distributor
- 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.
- Lot
- phoenix micrornelx and nanomelx cabinet x-ray systems
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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