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Recall Observatory FDA recall evidence

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.

Z-2870-2017

July 24, 2017

Class II

Product summary

Firm
X-Laser Llc
Event
Event 77843
Status
Terminated
Classification
Class II
Quantity
830
Official record key
device-enforcement:Z-2870-2017

Official wording

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

Code information: LLS projectors

Distribution pattern: US Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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