Events

Retiro De Equipo (Recall) de Device Recall Nidek EC5000 Excimer Laser System, Final Fit Software Version 1.11 and 1.12

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
    76376
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1494-2017
  • Fecha de inicio del evento
    2017-02-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153003
  • 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
    Excimer laser system - Product Code LZS
  • Causa
    During treatment planning, the procedure was programmed with an unintended (wrong) correction.
  • Acción
    Nidek sent a Recall notification letter dated February 1, 2017 to all affected consignees by certified mail method beginning February 2, 2017. Letters advised of the issue received from a complaint and the steps the user took that created the issue. To prevent the issue, the letters provide steps that should be taken. Nidek's Customer Support team will contact customers by phone or email. Customers with questions were instructed to contact Customer Service at 1-800-223-9044 or email ff_support@nidek.com.

Device

Device Recall Nidek EC5000 Excimer Laser System, Final Fit Software Version 1.11 and 1.12
  • Modelo / Serial
    Software version 1.11 and 1.12. Serial numbers of Affected devices: MNE0009; NVE0002; OH00295; NC00185; CAE0016; COE0008; MI00131; GA00241; CAE0007; VAE0004; MI00131; CAE0031; AZ00167; COE0011; CA00561; PAE0003; TN00168; MNE0009; WA00246; CAE0047; OHE0005; WAE0008; MI00244; NY00473; CAE0007; WAE0008; NVE0002; WA00233; CAE0016.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.
  • Descripción del producto
    Final Fit Software Version 1.11 and 1.12; || PC Based software installed outside Nidek EC-5000 Excimer Laser System. || Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
  • 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