Z-2870-2017 Class II Terminated
FDA device recall Z-2870-2017 was initiated by X-Laser Llc on July 24, 2017 and is designated Class II. 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 The recall status is terminated (terminated April 16, 2024). Affected quantity: 830.
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2017
- Initiation Date
- July 24, 2017
- Termination Date
- April 16, 2024
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 830
Product 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 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 Pattern
US Distribution
Code Information
LLS projectors