Recall Z-1942-2025— Spectral Instruments Inc
Class II · Ongoing
Class II FDA medical device recall by Spectral Instruments Inc, initiated 2025-05-13. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Spectral Instruments Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-13
- Firm location
- Tucson, AZ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.