Events

Retiro De Equipo (Recall) de Optovue RTVue, iVue

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 Optovue 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
    63211
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0024-2013
  • Fecha de inicio del evento
    2012-09-07
  • Fecha de publicación del evento
    2012-10-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113022
  • 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
    Tomography optical coherence - Product Code OBO
  • Causa
    Devices labeled for an intended use not included in the existing 510(k) or pma. specifically, "the retina" poster provided with the systems, and the book "retinal oct analysis and interpretation method" by bruno lumbroso and marco rispoli which are not labeled within 51o(k) cleared product description.
  • Acción
    Optovue Inc., sent a Voluntary Field Correction and Removal letter dated September 6, 2012, to all affected customers. The letter identified the product the problem and the action to be taken by the customer . Please sign and return the attached form indicating your acknowledgement that that the Affected Materials have been returned or destroyed. If you have any further questions please contact Optovue, at 1-866-344-8948.

Device

Optovue RTVue, iVue
  • Modelo / Serial
    All units of these models.
  • Clasificación del producto
    Ophthalmic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA (nationwide) and Internationally.
  • Descripción del producto
    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; || The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA || The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.
  • Manufacturer
    Optovue Inc.

Manufacturer

Optovue Inc.
  • Dirección del fabricante
    Optovue Inc., 2800 Bayview Dr, Fremont CA 94538-6518
  • Empresa matriz del fabricante (2017)
    Optovue Inc.
  • Source
    USFDA