Retiro De Equipo (Recall) de Device Recall Fraxel re:store Dual Laser System

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 Solta Medical, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • 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
    Powered laser surgical instrument with microbeam\fractional output - Product Code ONG
  • Causa
    The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.
  • Acción
    The firm, Solta Medical, issued three "DEVICE CORRECTION" letters, one dated December 15, 2010, the second one date December 17, 2010 and the third one dated December 20, 2010, to all affected customers. The letters described the product, problem and action to be taken by the customers. The customers were instructed to follow the instructions carefully, sign and date the bottom of the instruction form upon completion of the update and promptly return the signed form and USB stick in the enclosed, return-addressed envelope (Product Support, Solta Medical, 25881 Industrial Blvd., Hayward, CA 94545) Note: Solta Medical sales personnel will assist with the software update process so, if your local representative has already updated your system, you do not need to do anything further. If you have any questions, please call Solta Product Support at (510) 259-7291.


  • Modelo / Serial
    Serial Numbers: F1196J, J0007, J0010-J0058, J0060-J0203, J0205, J0207-J0209, J0211-J0337, J0339-J0359, J0361-J0414, J0417-J0419, J0426
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution: USA and countries including: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Egypt, Germany, Greece, Hong Kong, India, Italy, Japan, Korea, Kuwait, Mexico, Netherlands, New Zealand, Pakistan, Philippines, Poland, Russia, Singapore, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, and Vietnam
  • Descripción del producto
    Fraxel re:store¿ Dual Laser System----a laser surgical instrument for use in general and plastic surgery and in dermatology. || Model Numbers: MC-SYS-SR1500-D-US; MC-SYS-SR1500-D-US-LOANER; MC-SYS-SR1500-D-UPG-US; MC-SYS-SR 1500-0-1 NTL; MC-SYS-SR1500-D-I-LOANER; MC-SYS-SR1500-D-UPG-INTL; Product is manufactured and distributed by Solta Medical, Inc., Hayward, CA || The Fraxel re:store¿ Dual Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue.
  • Manufacturer


  • Dirección del fabricante
    Solta Medical, Inc., 25881 Industrial Blvd, Hayward CA 94545-2991
  • Empresa matriz del fabricante (2017)
  • Source