FDAAugust 8, 2024device
Fusion Pro 24, Model 17000
Official recall recorded by the U.S. Food & Drug Administration.
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 enforcement status: Ongoing
Brands named
epilog laserepilog
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDALaser light show projectors manufactured by BLS, Model PURE 5000/10000.2025-06-30
- FDALaser light show projectors manufactured by BLS, Model CLUB 1000/2000/4000.2025-06-30
- FDALaser light show projectors manufactured by BLS, Model DIODE 1000/2000/3000.2025-06-30
- FDAClass IV New Era medical laser device2020-01-29
- FDAX-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector.2017-07-24
- FDABeijing Syntech Laser UL C02 Laser surgical lasers2017-07-03
- FDABeijing Syntech Laser Trixel C02 Laser surgical lasers2017-07-03
- FDABeijing Syntech Laser Diode Laser surgical lasers2017-07-03
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