PlainRecalls
FDA Devices Moderate Class II Ongoing

Lago X

Reported: June 25, 2025 Initiated: May 13, 2025 #Z-1941-2025

Product Description

Lago X

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.

Details

Recalling Firm
Spectral Instruments Inc
Units Affected
39
Distribution
US
Location
Tucson, AZ

Frequently Asked Questions

What product was recalled?
Lago X. Recalled by Spectral Instruments Inc. Units affected: 39.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 25, 2025. Severity: Moderate. Recall number: Z-1941-2025.