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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Spectral Instruments Lago X and Ami HTX Recalled for Incorrect Safety Labels

Agency Publication Date: June 18, 2025
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Summary

Spectral Instruments Inc. is recalling approximately 73 units of its Lago X and Ami HTX imaging instruments because the X-ray safety and manufacturing date labels are incorrect. These labels do not match the specific safety requirements set by the FDA. While the instruments' physical functions are not affected, the labels must be corrected to ensure compliance with radiation safety standards. No injuries or incidents have been reported.

Risk

Incorrect X-ray safety labels may fail to provide users with accurate regulatory information regarding the device's radiation components. This could lead to a misunderstanding of the device's manufacturing specifications or safety compliance status.

What You Should Do

  1. This recall involves Spectral Instruments imaging devices, including the Lago X (identified by Accession number 2510787-000) and the Ami HTX (identified by Accession number 2510780-000).
  2. Locate the manufacturing and safety labels on your instrument to verify the Accession number and manufacturing date.
  3. Stop using the recalled product.
  4. Contact Spectral Instruments Inc. or your equipment distributor immediately to arrange for the delivery of corrected labels or for a technician to perform a device correction.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions or need further assistance.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Lago X
Model / REF:
Accession number 2510787-000

Recall number: Z-1941-2025; Quantity distributed: 39

Product: Ami HTX.
Model / REF:
Accession number 2510780-000

Recall number: Z-1942-2025; Quantity distributed: 34

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97035
Status: Active
Manufacturer: Spectral Instruments Inc
Sold By: Spectral Instruments Inc
Manufactured In: United States
Units Affected: 2 products (39; 34)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.