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Spectral Instruments Inc: Ami HTX

Medical DevicesSource: FDA (device) · Date: 2026-08-26

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Spectral Instruments Inc
Product
Ami HTX
Reason / hazard
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
Classification
Class II
Status
Ongoing
Distribution / sold at
United States.
Recall initiated
2026-07-24
Code info
All serial numbers.
Product quantity
35
Voluntary mandated
FDA Mandated
City
Tucson
State
AZ
Country
United States
Event id
99631
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