[pending] Lago X
Pending LLM rewrite. Source: FDA_DEVICE Z-1941-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
The recalled product
- Product
- Lago X
- Manufacturer
- Spectral Instruments Inc
- Category
- Medical Device — Devices
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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