FDA Medical devices recall ·
Lago X recall
- Recall number
- Z-1941-2025
- Date
- (initiated May 13, 2025)
- Company / brand
- Spectral Instruments Inc
420 N Bonita Ave, Tucson, AZ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 39
- Initiated by
- FDA Mandated
Read the official FDA notice ↗
Product
Lago X
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Accession number 2510787-000
Distribution
US
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1941-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.