Z-1231-2016 Class II Terminated
FDA device recall Z-1231-2016 was initiated by GE Inspection Technologies, LP on December 16, 2015 and is designated Class II. 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 st… The recall status is terminated (terminated October 14, 2016). Affected quantity: 55 US Distribution.
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2016
- Initiation Date
- December 16, 2015
- Termination Date
- October 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 US Distribution
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)
Distribution Pattern
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