FDAFDA · Food and drugs·Recall number Z-1942-2025
Ami HTX.
Published June 25, 2025 · Recall initiated: May 13, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Spectral Instruments Inc
- Distributor
- US
- Lot
- Accession number 2510780-000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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