FDA Enforcement
Class II
Ongoing
Ami HTX.
Recall: Z-1942-2025
·
Reported June 25, 2025
Enforcement
- Recall Number
- Z-1942-2025
- Event ID
- 97035
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Spectral Instruments Inc
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- June 25, 2025
- Initiation Date
- May 13, 2025
- Classification Date
- June 18, 2025
- Address
- 420 N Bonita Ave, N/A, Tucson, AZ, 85745-2747, United States
Description
Ami HTX.
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.
Code Info
Accession number 2510780-000
Distribution
US
Quantity
34