Events

Retiro De Equipo (Recall) de Device Recall Dual Delivery 4DD1 of GYC1000 Green Laser Photocoagulator system GYC4DD1:

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 Nidek 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
    71527
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2067-2015
  • Fecha de inicio del evento
    2015-03-25
  • Fecha de publicación del evento
    2015-07-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138108
  • 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
    Accessories to the gyc-1000 laser were missing laser aperture labels.
  • Acción
    Nidek sent Recall Notifications to doctors on March 31, 2015, by Federal Express. Letters were specific to the accessory involved. NIDEK detected that the laser aperture label has not been affixed on the delivery unit of GYC-1000, Green Laser Photocoagulator System and the device does not meet FDA regulation 21 CFR Subchapter J. In order to comply with FDA regulation, Nidek requests that the customer affix the enclosed laser aperture label to the Dual Delivery 4DD-1 of GYC-1000, according to the instructions attached. Please see the enclosed Laser Aperture label, instruction for affixing to the device and the response card. Nidek requests that you complete and return the response card as soon as possible. For additional information, please call Nidek at 1-800-223-9044 or visit http://usa.nidek.com

Device

Device Recall Dual Delivery 4DD1 of GYC1000 Green Laser Photocoagulator system GYC4DD1:
  • Modelo / Serial
    Model GYC4DD-1
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.
  • Descripción del producto
    Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system || GYC4DD-1: || The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
  • Manufacturer
    Nidek Inc

Manufacturer

Nidek Inc
  • Dirección del fabricante
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • Empresa matriz del fabricante (2017)
    Nidek Co. Ltd.
  • Source
    USFDA