Recall archive / FDA device enforcement
Ami HTX — FDA record Z-2940-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 24, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Ami HTX
- Reason
- Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
- Classification
- Class II
- Recalling firm
- Spectral Instruments Inc
- Quantity
- 35
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2940-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | All serial numbers. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
United States.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Aug 26, 2026
- Recall initiation date
- Jul 24, 2026
- Center classification date
- Sep 4, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.