Lago X X-ray instrument recall due to labeling discrepancies
Spectral Instruments Inc is recalling the Lago X X-ray instrument because its safety and manufacturing date labels do not match FDA 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: The recall is an FDA Class II medical device recall for a labeling discrepancy with no reported injuries or safety incidents. Labeling errors that do not involve missing critical safety information on high-risk devices are typically classified as moderate.
Plain-English summary
Spectral Instruments Inc is recalling the Lago X X-ray instrument. The X-ray safety and manufacturing date labels affixed to the device do not correspond exactly to the labeling stipulated by the FDA/CDRH.
Affected units include 39 Lago X instruments distributed in the US. The device in question is identified by accession number 2510787-000.
Consumers who have purchased this device should contact Spectral Instruments Inc for further guidance regarding the labeling discrepancy.
The recalled product
- Product
- Lago X
- Manufacturer
- Spectral Instruments Inc
- Category
- Medical Device — X-ray Equipment
- Hazard
- mis-labeling
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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