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Open, Classified

Lago X

FDA Recall Z-1941-2025 · Posted 2025-06-18

Recalling FirmSpectral Instruments Inc
Recall StatusOpen, Classified
Product CodeRCE
Date Initiated2025-05-13
Product Quantity39

Reason for Recall

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.

Firm Action

Sent packets by Fed-Ex, containing corrected physical labels to all affected customers who possess either Lago X or AMI HTX instruments shipped before 01/01/2025.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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