Events

Retiro De Equipo (Recall) de Device Recall Vycor Medical ViewSite Brain Access System

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 Vycor 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
    63319
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0673-2013
  • Fecha de inicio del evento
    2012-08-21
  • Fecha de publicación del evento
    2013-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-05-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113513
  • 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
    Retractor, self-retaining, for neurosurgery - Product Code GZT
  • Causa
    Vycor medical recalled their vbas (vycor viewsite brain access system) because an unidentified black fiber was found on the device.
  • Acción
    Vycor Medical, Inc. notified all customers of the product recall by telephone and follow-up letter. Customers were instructed to quarantine affected products and hold the shipment(s) in quarantine unti further notice. The units will be replaced with inspected and passed units. All distributors were instructed to notify their customers of the recall and ask to have them return their stock. For question call 561-558-2020.

Device

Device Recall Vycor Medical ViewSite Brain Access System
  • Modelo / Serial
    Model # TC171105 Lot # VM83450
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.
  • Descripción del producto
    Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** || Product Usage: || The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
  • Manufacturer
    Vycor Medical, Inc.

Manufacturer

Vycor Medical, Inc.
  • Dirección del fabricante
    Vycor Medical, Inc., 6401 Congress Ave Ste 140, Boca Raton FL 33487-2841
  • Empresa matriz del fabricante (2017)
    Vycor Medical, Inc.
  • Source
    USFDA