Lago X
This recall is currently active, issued June 18, 2025. It was issued by Spectral Instruments Inc.
- Company
- Spectral Instruments Inc
- Recall Initiated
- May 13, 2025
- Posted
- June 18, 2025
- Recall Number
- Z-1941-2025
- Quantity
- 39
- Firm Location
- Tucson, AZ
- Official Source
- View on FDA website ↗
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.
Distribution
US
Lot / Code Info
Accession number 2510787-000
Root 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.
More recalls by Spectral Instruments Inc
Ami HTX.
Jun 18, 2025