FDA-Device2024-12-11Class II
Fusion Pro 24, Model 17000
Epilog Laser Corp.
Hazard
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.
Sold states
US Nationwide Distribution
Affected count
751
Manufactured in
16371 Table Mountain Pkwy, Golden, CO, United States
Products
Fusion Pro 24, Model 17000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0524-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief