FDA-Device2026-08-26Class IIPROCESSING DEFECT
Spectral Instruments Ami HTX X-ray system recalled for missing on-screen safety indicator
What this means
The Ami HTX X-ray system may briefly fail to display the "X-Ray On" banner during the run readiness check. This missing visual indicator could create confusion about whether the X-ray is active. No injuries have been reported.
- If you operate an Ami HTX system, contact Spectral Instruments Inc for instructions or a firmware update
- Verify the X-ray status through alternative confirmation methods until the issue is resolved
The agency's original wording
Hazard
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
Intended for
All ages
Illnesses reported
None reported
Sold states
United States.
Affected count
35
Manufactured in
420 N Bonita Ave, Tucson, AZ, United States
Products
Ami HTX
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2940-2026More Spectral Instruments recalls
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