Events

Retiro De Equipo (Recall) de Device Recall RevLite SI Laser

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 ConBio, a CynoSure Company.

¿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
    65407
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1599-2013
  • Fecha de inicio del evento
    2013-05-09
  • Fecha de publicación del evento
    2013-06-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118789
  • 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 - Product Code GEX
  • Causa
    An inconsistency was identified related to electronic display identification of the optional multilite dye handpieces of the revlite si laser system that may confuse user.
  • Acción
    The firm, Cynosure Inc., sent a "MEDICAL DEVICE FIELD ACTIONS NOTIFICATION" letter dated May 9, 2013 to its customers via UPS next day. The letter described the product, problem and actions to be taken. The customers were instructed to immediately stop using the Revlite SI Multilite Dye Handpieces upon receipt of this letter and complete and return the enclosed Field Corrective Action Acknowledgement Form via e-mail to: mflynn@cynosure.com or FAX to: 978-256-6556. A Cynosure representative will be contacting customers to schedule and arrange an exchange of the affected handpieces. If additional information is required please contact VP of Regulatory Affairs and Quality Systems at 978-367-2350 or via email at ikulinets@cynosure.com.

Device

Device Recall RevLite SI Laser
  • Modelo / Serial
    659-1050-585 nm Handpiece; Manufacturer numbers: 659-1050 / C13B1141 659-1050 / D13C1151 659-1050 / D13C1157 659-1050 / D13C1158 659-1050 / D13C1160 659-1050 / D13C1154 Model 659-1100 - 650 nm Handpiece; manufacturer numbers: 659-1100 / C13B1141 659-1100 / D13C1151 659-1100 / D13C1157 659-1100 / D13C1158 659-1100 / D13C1160 659-1100 / D13D1165.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: IL, ME, NM and VA; and countries of: Australia and Chile.
  • Descripción del producto
    Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. || The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. || Manufactured by: || ConBio, A Cynosure Company || 47733 Fremont blvd || Fremont, CA 94538
  • Manufacturer
    ConBio, a CynoSure Company

Manufacturer

ConBio, a CynoSure Company
  • Dirección del fabricante
    ConBio, a CynoSure Company, 47733 Fremont Blvd, Fremont CA 94538-6512
  • Source
    USFDA