Reported Jun 25, 2025 · Ongoing
Ami HTX.
Spectral Instruments Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spectral Instruments Inc · 420 N Bonita Ave · Tucson, AZ · 85745-2747
Is this the product you have?
- Ami HTX.
- Lot codes and dates
- Accession number 2510780-000
- Amount recalled
- 34
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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