Spectral Instruments Inc recalls Ami HTX.
- Recall date
- May 13, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1942-2025
- FDA classification
- Class II
- Brand / firm
- Spectral Instruments Inc
- Sold / distributed
- US
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ami HTX.
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