Z-2940-2026Class II

Ami HTX

Name: Z-2940-2026 Ami HTX
Creator: Spectral Instruments Inc
Published: 2026-07-24
License: https://open.fda.gov/license/

Spectral Instruments Inc / initiated 2026-07-24 / Open, Classified

FDA source

Spectral Instruments Inc began a recall of Ami HTX on 2026-07-24. FDA classified it as Class II and gives the reason as "Momentary absence of On-Screen "X-Ray On" banner during run readiness check". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2940-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-24
Posted: 2026-08-14
Recalling firm: Spectral Instruments Inc
Product: Ami HTX
Product code: RCE Cabinet X-Ray, Industrial
Reason for recall: Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
FDA root cause: Radiation Control for Health and Safety Act
Action: Customer notification letters dated August 21, 2023 and allows for scheduling of the software upgrade corrections.
Quantity in commerce: 35
Distribution: United States.
Product codes and lots: All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2940-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2939-2026	Class II	Ongoing	FDA Mandated	2026-08-26	2026-09-04
Z-2940-2026	Class II	Ongoing	FDA Mandated	2026-08-26	2026-09-04

Product code RCE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)