FDA recall, , Moderate risk
Spectral Instruments Lago X and Ami HTX Imaging Systems
Lago X has a momentary absence of the on-screen X-Ray On banner during a readiness check.
Summary by Recall Canary from the FDA notice
What happened
Spectral Instruments Inc of Tucson, Arizona recalled Lago X and Ami HTX products. The recall began July 24, 2026, and was added to the FDA's Enforcement Report on August 14, 2026. The reason is a momentary absence of the on-screen X-Ray On banner during a run readiness check. The products were distributed in the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Every lot is recalled. There's no code to check.
Ami HTX
- Lot code
- All serial numbers
Lago X
- Lot code
- All serial numbers
Recall details
- Company began the recall
- Sold in
United States.
- Company
- Spectral Instruments IncTucson, Arizona
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99631
- Recall numbers
- Z-2939-2026 to Z-2940-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Classified by FDA
Summary updated
