FDA Device recall Z-1942-2025
Ami HTX
- FDA Device
- Class II
- ongoing
- Published 2025-06-25
On 2025-06-25 the FDA classified a Class II recall of Ami HTX by Spectral Instruments, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1942-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-13 |
| Published | 2025-06-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Spectral Instruments |
| Distribution | n/a |
Product
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.
Identifiers
| code_info | Accession number 2510780-000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1942-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.