Events

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

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by X-Laser Llc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77843
  • Event Risk Class
    Class 2
  • Event Number
    Z-2870-2017
  • Event Initiated Date
    2017-07-24
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158026
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    High-power laser light show projector - Product Code REA
  • 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.

Device

Device Recall Aurora, Caliente Aurora, PSX400, Mobile Beat Max, Mobile Beat Max MKII, Xbeam, and...
  • Model / Serial
    LLS projectors
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    US Distribution
  • 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.
  • Manufacturer
    X-Laser Llc

Manufacturer

X-Laser Llc
  • Manufacturer Address
    X-Laser Llc, 9125 Whiskey Bottom Rd Ste A, Laurel MD 20723-1333
  • Manufacturer Parent Company (2017)
    Xlaser
  • Source
    USFDA