FDA Recall
Open, Classified
Lago X
Recall: Z-1941-2025
·
Initiated May 13, 2025
Recall
- Recall Number
- Z-1941-2025
- Event Number
- 97035
- Firm
- Spectral Instruments Inc
- FEI Number
- 3002679892
- Product Code
- RCE
- Status
- Open, Classified
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- May 13, 2025
- Posted
- June 18, 2025
- Address
- 420 N Bonita Ave, Tucson, AZ, 85745-2747
Description
Lago X
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.
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.
Distribution
US
Quantity
39