Medical Device Recall: Fusion Pro 24, Model 17000
Epilog Laser Corp. · August 8, 2024
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
States Affected
NATIONWIDE
Quantity Affected
751
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0524-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.