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Open, Classified

Ami HTX

FDA Recall Z-2940-2026 · Posted 2026-08-14

Recalling FirmSpectral Instruments Inc
Recall StatusOpen, Classified
Product CodeRCE
Date Initiated2026-07-24
Product Quantity35

Reason for Recall

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

Firm Action

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

Distribution Pattern

United States.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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