Medical device recalls Moderate risk

Epilog Laser Corp. recalls Fusion Pro 24, Model 17000

Recall date
August 8, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0524-2025
FDA classification
Class II
Brand / firm
Epilog Laser Corp.
Sold / distributed
US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Fusion Pro 24, Model 17000

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