Recall Z-1942-2025
Spectral Instruments Inc · initiated May 13, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Ami HTX.
Codes / lots: Accession number 2510780-000
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.
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
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.
Details
- Recall number
- Z-1942-2025
- Initiated
- May 13, 2025
- Posted by FDA
- June 18, 2025
- Product code
- RCE – Cabinet X-Ray, Industrial
- Quantity
- 34
- Distribution
- US
- Recalling firm
- Spectral Instruments Inc, Tucson, AZ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1941-2025 Class II | Lago XThe X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond… | 05/13/2025Open, Classified |