Class II
Medical Device Recall: Ami HTX.
Spectral Instruments Inc · May 13, 2025
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.
Distribution
US
Quantity Affected
34
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1942-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.