Recall Z-1942-2025 ยท RCE Cabinet X-Ray, Industrial
Spectral Instruments Inc
Ami HTX.
| Date | Jun 18, 2025 (initiated May 13, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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 | 34 |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.