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Open, Classified

Fusion Pro 24, Model 17000

FDA Recall Z-0524-2025 · Posted 2024-12-03

Recalling FirmEpilog Laser Corp.
Recall StatusOpen, Classified
Product CodeRHK
Date Initiated2024-08-08
Product Quantity751

Reason for Recall

a. A small number of Fusion Pro 24 units were released with an incorrectly placed Interlock device. As a result, the system can be operated with the front-loading door in an open position. b. Fails to comply with Class 2 designation, indicated in Part 6 of Laser Product Report. An incorrectly placed Interlock device can allow Class 4 laser radiation fields during operation.

Firm Action

The measures to be taken to repair such defect or to bring the product into compliance with the Federal standard. This Recall provides corrections by repair to a defective safety interlock location by a kit with comprehensive instructions, offered at no cost to purchasers

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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