Lago X
FDA device recall Z-1941-2025 · posted 2025-06-18 · Open, Classified
Recall details
- Recalling firm
- Spectral Instruments Inc
- 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.
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- RCE
- Quantity affected
- 39
- Distribution
- US
- Date initiated
- 2025-05-13
- Date posted
- 2025-06-18
- Location
- Tucson, AZ
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