FDA Enforcement
Class II
Terminated
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.
Recall: Z-2870-2017
·
Reported September 20, 2017
Enforcement
- Recall Number
- Z-2870-2017
- Event ID
- 77843
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- X-Laser Llc
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- September 20, 2017
- Initiation Date
- July 24, 2017
- Classification Date
- September 13, 2017
- Termination Date
- April 16, 2024
- Address
- 9125 Whiskey Bottom Rd Ste A, N/A, Laurel, MD, 20723-1333, United States
Description
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
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 Info
LLS projectors
Distribution
US Distribution
Quantity
830