FDA recall Z-2870-2017

X-Laser Llc · Class II · device

Product

X-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.

Reason for recall

Failure to comply with performance standard requirements (21 CFR 1040.10(f))when operated in the user accessible auto and music modes of operation

Distribution

US Distribution

Key facts

Status
Terminated
Initiation date
2017-07-24
Report date
2017-09-20
Termination date
2024-04-16
Voluntary/Mandated
FDA Mandated
Location
Laurel, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2870-2017