Retiro De Equipo (Recall) de Prism Laser 7642

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 American Stress Technologies, Inc..

¿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
    58804
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2600-2011
  • Fecha de inicio del evento
    2011-04-27
  • Fecha de publicación del evento
    2011-08-29
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2016-10-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Analytical measuring and detection laser product - Product Code REO
  • Causa
    It was discovered the prism 7642 was not certified at the time of delivery. the product lacks the required labeling and the product was sold and delivered without the submission of the initial product report. the product lacks user in formation.
  • Acción
    American Stress Technologies sent a customer notification letter dated April 1, 2011, informing them of the action they have taken to correct this issue. (1) ASTI conducted laser safety tests and checks on May 3,2011 to verify the Prism was compliant with FDA regulations. This was confirmed in a June 17, 2011, electronic mail message. (2) ASTI placed the required labels described in the initial product report on the Prism on May 3, 2011. (3) ASTI delivered updated user manuals to UNO on May 3, 2011, that describe potential laser hazards and the required labeling in the same way as described in the initial product report. (4) ASTI completed the above corrective actions at no cost to UNO as confirmed in a June 20, 2011, electronic mail message. If you have any further questions please call (724) 410-1030

Device

  • Modelo / Serial
    S/N 7642/2009
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Prism Laser 7642 || Laser System
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    American Stress Technologies, Inc., 840 Watercrest Way, Cheswick PA 15024
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA