UnratedMedical device recall · FDA · Published May 13, 2025
Spectral Instruments Ami HTX X-ray Safety Label Recall
Spectral Instruments recalls Ami HTX X-ray instruments due to mismatched FDA-compliant safety labels. Affected units may not meet regulatory standards for radiation safety.
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.
Take action
Contact the company
📍Recalling firmSpectral Instruments Inc420 N Bonita Ave · Tucson, AZ 85745-2747
✎ GovInfoNow plain-language explainer
Spectral Instruments is recalling its Ami HT: X-ray instruments because the safety and manufacturing date labels on the devices don't match FDA requirements. This mismatch could lead to improper radiation safety labeling, potentially affecting patient or operator safety. Read more at govinfonow.com/recall/52281-spectral-instruments-ami-htx-x-ray-safety-label-recall.
“Spectral Instruments Ami HTX X-ray Safety Label Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52281-spectral-instruments-ami-htx-x-ray-safety-label-recall. Based on FDA recall #Z-1942-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1942-2025%22&limit=1).
The FDA announced on May 13, 2025, that Spectral Instruments Inc is recalling the Ami HTX X-ray instrument. The hazard involves safety and manufacturing date labels that do not match FDA stipulations.
How to tell if you have it
Brand: Spectral Instruments
Product: Ami HTX
Accession number: 2510780-000
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.
Context
GovInfoNow's records show Spectral Instruments Inc has one other recall on record since July 24, 2026. Other recent recalls of similar products include Philips IQon Spectral CT Software 4.7.7.x Recall (Aug. 7, 2026), GE Medical Systems Senographe Pristina Mammography Machines: Missing X-Ray Warning Label (Oct. 24, 2025), and Philips Brilliance CT 64 Medical Scanner Recall (Aug. 7, 2026).
How to tell if you have this one
Check for the Ami HTX X-ray instrument with a label that shows the safety and manufacturing date. The product was sold by Spectral Instruments or authorized dealers.
Brand
Spectral Instruments
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US
Recall number
Product, codes & lots
Quantity
Z-1941-2025
Lago X; Accession number 2510787-000
39
Z-1942-2025
Ami HTX.; Accession number 2510780-000
34
Based on the official FDA remedy
What to do — step by step
Check Labels
Verify the X-ray safety and manufacturing date labels on the Ami HTX instrument to ensure they match FDA requirements.
How this recall unfolded
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1942-2025 (May 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1942-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.