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.
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 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
- Affected units
- 39
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.
Part of a larger recall action
This product is one of 2 recalled by Spectral Instruments Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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