CLASS II ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report
Ami HTX recalled by Spectral Instruments
Spectral Instruments is recalling Ami HTX. The recall was initiated on 24 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2940-2026
- FDA event ID
- 99631
- Recalling firm
- Spectral Instruments, Tucson, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jul 2026
- FDA classified
- 4 Sep 2026
- Reported
- 26 Aug 2026
- Type
- FDA Mandated
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Jul 2026 | Recall initiated by company | |
| 26 Aug 2026 | Published in enforcement report | +33 days |
| 4 Sep 2026 | Classified by FDA | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
Product as listed by the FDA
Ami HTX
Where it was distributed
United States.
Questions about this recall
Why was it recalled?
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
Which lots are affected?
All serial numbers.
Where was it sold?
United States.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99631This product is part of a recall event; the main page for the event is Lago recalled by Spectral Instruments.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lago recalled by Spectral Instruments | Spectral Instruments | Other | AZ |
More recalls from Spectral Instruments
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Lago recalled by Spectral Instruments | Spectral Instruments | Other | AZ |
| Device | CLASS II | Lago recalled by Spectral Instruments | Spectral Instruments | Other | AZ |
| Device | CLASS II | Ami HTX recalled by Spectral Instruments | Spectral Instruments | Other | AZ |
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