Device product
GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
Z-1231-2016
Product summary
- Event
- Event 73364
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 US Distribution
- Official record key
device-enforcement:Z-1231-2016
Official wording
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 information: phoenix micrornelx and nanomelx cabinet x-ray systems
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.
Derived failure modes
-
Unknown
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)