GE Laser Centering Device Recalled for Regulatory Non-Compliance
GE Inspection Technologies is recalling 25 laser centering devices for X-ray generators due to potential failure to comply with federal regulations.
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 source text cites regulatory non-compliance without reporting any injuries, illnesses, or specific physical hazards, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
GE Inspection Technologies, LP is recalling 25 units of the GE Optional Laser Centering Device for X-ray generators. The recall was initiated because the company identified a potential failure to comply with 21 C.F.R. § 1040.10 and 21 C.F.R. § 1010.2 regarding the alignment laser centering device.
The affected devices are Model No. 025.03.00A. These units were distributed in the United States to the states of New York, California, Washington, Pennsylvania, Maryland, Alabama, Florida, and Louisiana.
The source text does not specify specific actions for consumers or the exact nature of the regulatory violation beyond the cited codes. Users of these devices should contact GE Inspection Technologies, LP for further instructions.
The recalled product
- Product
- GE Optional Laser Centering Device X-ray generator.
- Manufacturer
- GE Inspection Technologies, LP
- Affected units
- 25
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)
- Model No. 025.03.00A
Distribution
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