Recall Z-0524-2025— Epilog Laser Corp.
Class II · Ongoing
Class II FDA medical device recall by Epilog Laser Corp., initiated 2024-08-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Epilog Laser Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-08
- Firm location
- Golden, CO, United States
Product description
Fusion Pro 24, Model 17000
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.