FDA Recall 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 · Initiated July 24, 2017

Recall

Recall Number
Z-2870-2017
Event Number
77843
Firm
X-Laser Llc
FEI Number
3010087512
Product Code
REA
Status
Terminated
Root Cause
Device Design
Initiated
July 24, 2017
Terminated
April 16, 2024
Address
9125 Whiskey Bottom Rd, Ste A, Laurel, MD, 20723-1333

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

Action

X-Laser LLC will bring into compliance: 1. All purchasers and associated dealers of affected LLS projector models will be notified by mail and email of their failure to comply with the performance standard. The notification will follow the format and include the information required by 21 CFR 1003.21. Those that do not respond within 14 days will be notified a second time. Those not responding to the second attempt will be notified again every 6 months for the next 2 years. Non-responsive dealers will be ineligible for future orders. 2. All affected LLS projectors will be repaired by removing the auto and music modes from the dipswitch accessible settings, after which, these modes will only be accessible through the DMX connection. These actions, including transportation of the LLS projector, will be made free of charge. 3. All LLS projector models that X-Laser receives, regardless of purpose, will be checked for dipswitch accessible auto or music modes and repaired if needed. 4.Corrective actions will be completed within 120 days of receipt of this letter. For further questions please call (866) 702-7768.

Distribution

US Distribution

Quantity

830