Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1941-2025 — Lago X

U.S. FDA — Device Enforcement · United States · 2025-05-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1941-2025
Date of alert
2025-05-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Spectral Instruments Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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