FDA-Device2026-08-26Class IIPROCESSING DEFECT
Spectral Instruments Lago X X-ray system recalled for missing on-screen safety indicator
What this means
The Lago X X-ray system may briefly fail to display the "X-Ray On" safety banner during the run readiness check. This could create confusion about whether the system is actively emitting radiation. No injuries have been reported.
- If you operate a Lago X system, contact Spectral Instruments Inc for guidance on the remedy or corrective action
- Do not use the system if you cannot confirm the X-ray status during readiness checks until advised by the manufacturer
The agency's original wording
Hazard
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
Intended for
Adults
Illnesses reported
None reported
Sold states
United States.
Affected count
40
Manufactured in
420 N Bonita Ave, Tucson, AZ, United States
Products
Lago X
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2939-2026More Spectral Instruments recalls
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