GE Blade|line Industrial Cabinet X-ray System Recalled for Emission Violations
GE Inspection Technologies is recalling 13 Blade|line Industrial Cabinet X-ray systems because they exceed federal emission limits in an inaccessible crawl space.
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, but the hazard is limited to an area not intended to be accessed, and no injuries or illnesses are reported, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
GE Inspection Technologies, LP is recalling 13 units of the Blade|line Industrial Cabinet X-ray system. The recall was initiated because the systems fail to comply with the cabinet x-ray performance standard's emission limit of 0.5 milliRoentgen in one hour (21 CFR 1020.40(c)(1)(i)) underneath the bottom center of the system.
The affected crawl space is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed. The recall covers units distributed in the United States to the states of Alabama, South Carolina, Ohio, Michigan, and Pennsylvania, as well as internationally to Germany and Singapore.
Affected units are identified by the following serial numbers: TM 201317, TM 201312, TM 201323, TM 201331, TM 201401, TM 201329, TM 201404, TM 201413, TM 201414, TM 201415, TM 201424, TM 201425, and 158017R1. Users should contact GE Inspection Technologies for instructions on how to resolve the compliance issue.
The recalled product
- Product
- GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
- Manufacturer
- GE Inspection Technologies, LP
- Hazard
- Affected units
- 13
Distribution
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