Ami HTX
FDA device recall Z-2940-2026 · posted 2026-08-14 · Open, Classified
Recall details
- Recalling firm
- Spectral Instruments Inc
- Reason for recall
- Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
- Action taken
- Customer notification letters dated August 21, 2023 and allows for scheduling of the software upgrade corrections.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- RCE
- Quantity affected
- 35
- Distribution
- United States.
- Date initiated
- 2026-07-24
- Date posted
- 2026-08-14
- Location
- Tucson, AZ
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