Ami HTX.
Reported: June 25, 2025 Initiated: May 13, 2025 #Z-1942-2025
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.
Details
- Recalling Firm
- Spectral Instruments Inc
- Units Affected
- 34
- Distribution
- US
- Location
- Tucson, AZ
Frequently Asked Questions
What product was recalled? ▼
Ami HTX.. Recalled by Spectral Instruments Inc. Units affected: 34.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 25, 2025. Severity: Moderate. Recall number: Z-1942-2025.
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