The Recall Desk
ModerateFDA (Devices)·Z-2777-2017·Announced 2017-08-09

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.

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, 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
Affected units
13

Distribution

Distributed in 5 states:

Same manufacturer · GE Inspection Technologies, LP

See all →