Skip to content
Recall Observatory FDA recall evidence

Device product

Fusion Pro 24, Model 17000

Z-0524-2025

August 08, 2024

Class II

Product summary

Firm
Epilog Laser Corp.
Event
Event 95757
Status
Ongoing
Classification
Class II
Quantity
751
Official record key
device-enforcement:Z-0524-2025

Official wording

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.

Code information: Model 17000 Product Report Accession Number: 2021046-000

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.