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U.S. Department of Health and Human Services

Class 2 Device Recall Aurora, Caliente Aurora, PSX400, Mobile Beat Max, Mobile Beat Max MKII, Xbeam, and Hawk 500 models

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  Class 2 Device Recall Aurora, Caliente Aurora, PSX400, Mobile Beat Max, Mobile Beat Max MKII, Xbeam, and Hawk 500 models see related information
Date Initiated by Firm July 24, 2017
Create Date September 13, 2017
Recall Status1 Terminated 3 on April 16, 2024
Recall Number Z-2870-2017
Recall Event ID 77843
Product Classification High-power laser light show projector - Product Code REA
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.
Code Information LLS projectors
Recalling Firm/
Manufacturer		 X-Laser Llc
9125 Whiskey Bottom Rd Ste A
Laurel MD 20723-1333
For Additional Information Contact
866-702-7768
Manufacturer 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
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 830
Distribution US Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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