The Recall Desk
ModerateFDA (Devices)·Z-1231-2016·Announced 2016-04-13

GE Cabinet X-ray Systems Recalled for Non-Compliance with FDA Standards

GE Inspection Technologies is recalling 55 cabinet x-ray systems used for industrial quality control because they may not fully comply with FDA performance standards.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or deaths, indicating a theoretical or low-risk compliance issue.

Plain-English summary

GE Inspection Technologies, LP is recalling 55 cabinet x-ray systems used for industrial quality control. The affected models are the Phoenix Micronelx and Nanomelx cabinet x-ray systems.

The recall was initiated because GE discovered that these systems may not fully comply with the FDA's Cabinet X-ray System performance standards, specifically 21 C.F.R. § 1020.40(c)(1)(i). The agency has classified this as a Class II recall.

The affected units were distributed in the United States to the states of TX, MD, MI, CA, TN, NH, NY, AL, NC, ID, MA, AZ, IN, FL, PA, NJ, WI, VA, MN, CO, GA, SC, OH, and DC. Users of these systems should contact GE Inspection Technologies for further instructions on the recall.

The recalled product

Product
GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control.
Manufacturer
GE Inspection Technologies, LP
Category
Medical Device — Industrial X-ray
Hazard
Affected units
55

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • phoenix micrornelx and nanomelx cabinet x-ray systems

Distribution

Distributed in 24 states:

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