Spectral Instruments Inc recalls Ami HTX
Reason for recall
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Ami HTX
Lot / code information
All serial numbers.
What the firm is doing
Customer notification letters dated August 21, 2023 and allows for scheduling of the software upgrade corrections.
DistributionShow detailsHide
United States.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2940-2026
- FDA device classification · RCEOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Spectral Instruments IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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