Device recall

Ami HTX

FDA recall source

Recall number

Z-2940-2026

Event id

99631

Status

Ongoing

FDA classification

Class II

Recalling firm

Spectral Instruments Inc

Report date

Aug 26, 2026

Initiated

Jul 24, 2026

Center classification date

Sep 4, 2026

Reason

Momentary absence of On-Screen "X-Ray On" banner during run readiness check.

Quantity

35

Code info

All serial numbers.

Distribution

United States.

Voluntary or mandated

FDA Mandated

Location

Tucson, AZ, United States