FDA Medical devices recall ·
Ami HTX recall
- Recall number
- Z-2940-2026
- Date
- (initiated July 24, 2026)
- Company / brand
- Spectral Instruments Inc
420 N Bonita Ave, Tucson, AZ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 35
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Ami HTX
Why was it recalled?
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All serial numbers.
Distribution
United States.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2940-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.