Events

Retiro De Equipo (Recall) de Device Recall Imalux Niris OCT Imaging System Probe

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 Imalux Corporation.

¿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
    60911
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0934-2012
  • Fecha de inicio del evento
    2011-12-22
  • Fecha de publicación del evento
    2012-02-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106767
  • 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
    System, imaging, optical coherence tomography (oct) - Product Code NQQ
  • Causa
    During an fda inspection, the firm was notified that the wrong tubing was used during the manufacture of the probe for the unit.
  • Acción
    Imalux Corp contacted their one customer via telephone on December 14, 2011. They informed the customer of the problem and requested the probe returned. The probe involved was returned and received by Imalux on December 22, 2011, and will be stored offsite in quarantine. Any further questions please call (216) 502-0755 ext. 301.

Device

Device Recall Imalux Niris OCT Imaging System Probe
  • Modelo / Serial
    Model Number 1300, Serial Number F464019
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution only to Texas.
  • Descripción del producto
    Imalux Niris OCT Imaging System Probe, Model Number 1300, Serial Number F464019, IMALUX Corporation, Cleveland, OH || The Niris Imaging System probe is used with the Niris Imaging System. The Niris Imaging System employs Optical Coherence Tomography (OCT), which can be used to construct high spatial resolution. The probe, is attached to the Imaging Console, and is used to direct light to and from the patient tissue. A small electromechanical scanning mechanism in the probe moves the optical beam laterally across the tissue surface while simultaneously acquiring in-depth backscattering profile at each lateral position. The probe is not labeled or sold as sterile.
  • Manufacturer
    Imalux Corporation

Manufacturer

Imalux Corporation
  • Dirección del fabricante
    Imalux Corporation, 1771 E 30th St, Cleveland OH 44114-4407
  • Empresa matriz del fabricante (2017)
    Imalux Corp.
  • Source
    USFDA