Medical device recalls Moderate risk

Spectral Instruments Inc recalls Lago X

Recall date
May 13, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1941-2025
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

Lago X

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