FDA Recall
Open, Classified
Fusion Pro 24, Model 17000
Recall: Z-0524-2025
·
Initiated August 8, 2024
Recall
- Recall Number
- Z-0524-2025
- Event Number
- 95757
- Firm
- Epilog Laser Corp.
- FEI Number
- 3003468623
- Product Code
- RHK
- Status
- Open, Classified
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- August 8, 2024
- Posted
- December 3, 2024
- Address
- 16371 Table Mountain Pkwy, Golden, CO, 80403-1826
Description
Fusion Pro 24, Model 17000
Reason
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.
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
Distribution
US Nationwide Distribution
Quantity
751