Events

Retiro De Equipo (Recall) de Device Recall Aurora, Caliente Aurora, PSX400, Mobile Beat Max, Mobile Beat Max MKII, Xbeam, and Hawk 500 models

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por X-Laser Llc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    77843
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2870-2017
  • Fecha de inicio del evento
    2017-07-24
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158026
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    High-power laser light show projector - Product Code REA
  • Causa
    Failure to comply with performance standard requirements (21 cfr 1040.10(f))when operated in the user accessible auto and music modes of operation.
  • Acción
    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...
  • Modelo / Serial
    LLS projectors
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    US Distribution
  • Descripción del producto
    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
  • Dirección del fabricante
    X-Laser Llc, 9125 Whiskey Bottom Rd Ste A, Laurel MD 20723-1333
  • Empresa matriz del fabricante (2017)
    Xlaser
  • Source
    USFDA