Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2870-2017Class II

X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max...

X-Laser LLC / initiated 2017-07-24 / Terminated / root cause: design

X-Laser Llc began a recall of 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... on . FDA classified it as Class II and gives the reason as "Failure to comply with performance standard requirements (21 CFR 1040.10(f))when operated in the user accessible auto and music modes of operation". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2870-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
X-Laser LLC
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.
Product code
REA 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
Root cause tag
design
FDA root cause
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
Product codes and lots
LLS projectors

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2870-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2870-2017Class IITerminatedFDA Mandated