Lago X X-ray instruments recalled for incorrect safety and manufacturing labels
Spectral Instruments Inc is recalling 39 Lago X/AMI HTX X-ray instruments because the X-ray safety and manufacturing date labels do not match FDA labeling requirements.
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: This is a Class II medical device recall addressing a labeling compliance issue with no reported injuries or illnesses. The source describes only a discrepancy between affixed labels and FDA requirements, qualifying as a minor labeling error subject to a precautionary recall.
Plain-English summary
Spectral Instruments Inc is recalling 39 Lago X/AMI HTX X-ray instruments distributed in the United States. The X-ray safety and manufacturing date labels affixed to these devices do not correspond exactly to the labeling requirements stipulated by the FDA and CDRH (Center for Devices and Radiological Health).
The affected devices are identified by accession number 2510787-000. This labeling discrepancy represents a compliance issue with federal medical device regulations governing safety and manufacturing information presentation.
The recalled product
- Product
- Lago X
- Manufacturer
- Spectral Instruments Inc
- Hazard
- mis-labeling
- labeling-compliance
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)
- Accession number 2510787-000
Distribution
Distribution scope not specified by the agency.
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