FDA recall Z-0524-2025

Epilog Laser Corp. · Class II · device

Product

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.

Distribution

US Nationwide Distribution

Key facts

Status
Ongoing
Initiation date
2024-08-08
Report date
2024-12-11
Voluntary/Mandated
FDA Mandated
Location
Golden, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0524-2025