Epilog Laser Corp.: Device Recall
Recall #Z-0524-2025 · 08/08/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0524-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Epilog Laser Corp.
- Status
- Ongoing
- Date Initiated
- 08/08/2024
- Location
- Golden, CO, United States
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 751
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.
Product Description
Fusion Pro 24, Model 17000
Distribution Pattern
US Nationwide Distribution
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.