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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- 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
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