Events

Retiro De Equipo (Recall) de Device Recall IF 8000

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 Zynex 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
    Recall
  • ID del evento
    68447
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1874-2014
  • Fecha de inicio del evento
    2009-01-25
  • Fecha de publicación del evento
    2014-06-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127719
  • 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
    Stimulator, muscle, powered - Product Code IPF
  • Causa
    Zynex notified customers that a malfunction in the if 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.
  • Acción
    Consignees were notified via letter on 6/25/2009. The letter identified the reason for the recall, and stated that customers could contact customer service at 1-866-940-7030 if they encountered any difficulties with the affected product. Otherwise, they could continue using the product as they have in the past.

Device

Device Recall IF 8000
  • Modelo / Serial
    Serial No: 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and 28813400.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. || Designed for use in physical therapy, rehabilitation, and pain relief applications.
  • Manufacturer
    Zynex Medical, Inc.

Manufacturer

Zynex Medical, Inc.
  • Dirección del fabricante
    Zynex Medical, Inc., 9990 Park Meadows Dr, Lone Tree CO 80124-6739
  • Empresa matriz del fabricante (2017)
    Zynex Inc.
  • Source
    USFDA