FDA Enforcement
Class II
Terminated
GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
Recall: Z-1231-2016
·
Reported April 13, 2016
Enforcement
- Recall Number
- Z-1231-2016
- Event ID
- 73364
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- GE Inspection Technologies, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 13, 2016
- Initiation Date
- December 16, 2015
- Classification Date
- April 1, 2016
- Termination Date
- October 14, 2016
- Address
- 50 Industrial Park Rd, N/A, Lewistown, PA, 17044-9312, United States
Description
GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
Reason
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)
Code Info
phoenix micrornelx and nanomelx cabinet x-ray systems
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.
Quantity
55 US Distribution