Device product
Ami HTX.
Z-1942-2025
Product summary
- Event
- Event 97035
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 34
- Official record key
device-enforcement:Z-1942-2025
Official wording
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 information: Accession number 2510780-000
Distribution pattern: US
Derived failure modes
-
Unknown
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.