Spectral Instruments Inc: Device Recall
Recall #Z-1942-2025 · 05/13/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1942-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Spectral Instruments Inc
- Status
- Ongoing
- Date Initiated
- 05/13/2025
- Location
- Tucson, AZ, United States
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 34
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.
Product Description
Ami HTX.
Distribution Pattern
US
Other Recalls by Spectral Instruments Inc
- Class II: Risk 05/13/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.