Z-1942-2025 Class II Ongoing
FDA device recall Z-1942-2025 was initiated by Spectral Instruments Inc on May 13, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 34.
Recall Details
- Product Type
- Devices
- Report Date
- June 25, 2025
- Initiation Date
- May 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 34
Product Description
Ami HTX.
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.
Distribution Pattern
US
Code Information
Accession number 2510780-000