FDAFDA · Food and drugs·Recall number Z-0524-2025
Fusion Pro 24, Model 17000
Published December 11, 2024 · Recall initiated: August 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Epilog Laser Corp.
- Distributor
- US Nationwide Distribution
- Lot
- Model 17000 Product Report Accession Number: 2021046-000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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