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Recall Observatory FDA recall evidence

Device product

GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.

Z-1231-2016

December 16, 2015

Class II

Product summary

Firm
GE Inspection Technologies, LP
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

    reason.no_named_rule · v1.0.0

    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)

Field note

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