Z-1942-2025Class II
Ami HTX
Spectral Instruments Inc / initiated 2025-05-13 / Open, Classified / root cause: labeling and UDI
Spectral Instruments Inc began a recall of Ami HTX on . FDA classified it as Class II and gives the reason as "The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1942-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Spectral Instruments Inc
- Product
- Ami HTX.
- Product code
- RCE Cabinet X-Ray, Industrial
- Reason for recall
- The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.
- Root cause tag
- labeling and UDI
- FDA root cause
- Radiation Control for Health and Safety Act
- Action
- Sent packets by Fed-Ex, containing corrected physical labels to all affected customers who possess either Lago X or AMI HTX instruments shipped before 01/01/2025.
- Quantity in commerce
- 34
- Distribution
- US
- Product codes and lots
- Accession number 2510780-000
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1941-2025 | Class II | Ongoing | FDA Mandated | ||
| Z-1942-2025 | Class II | Ongoing | FDA Mandated |
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