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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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High RiskFDA Device
Other/Industrial & Commercial

Epilog Fusion Pro 24 Laser Systems Recalled for Radiation Exposure Risk

Agency Publication Date: December 3, 2024
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Summary

Epilog Laser Corp. is recalling 751 Fusion Pro 24 Laser Systems (Model 17000) because a manufacturing defect resulted in incorrectly placed safety interlock devices. This flaw allows the machine to operate while the front-loading door is open, exposing users to dangerous Class 4 laser radiation. No incidents or injuries have been reported to date, but the defect fails to comply with safety standards intended to protect operators from high-intensity radiation.

Risk

The incorrectly placed interlock device can allow the laser to stay active when the door is open, which poses a severe risk of permanent eye damage and serious skin burns upon contact with the Class 4 laser field.

What You Should Do

  1. The recalled products are Fusion Pro 24 Laser Systems, Model 17000, associated with Product Report Accession Number 2021046-000.
  2. Immediately stop using the recalled laser system and ensure it is disconnected from its power source to prevent accidental operation.
  3. Do not attempt to operate the laser with the loading door open or bypass any of the system's safety interlocks.
  4. Contact Epilog Laser Corp. or your authorized distributor to arrange for a formal inspection and a correction of the safety interlock device.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this medical device recall.

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: Fusion Pro 24
Model / REF:
17000

Product Report Accession Number: 2021046-000

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95757
Status: Active
Manufacturer: Epilog Laser Corp.
Sold By: authorized distributors
Manufactured In: United States
Units Affected: 751
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.