Events

Retiro De Equipo (Recall) de Device Recall Harmony HiResolution Bionic Ear 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 Advanced Bionics LLC.

¿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
    52700
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2039-2009
  • Fecha de inicio del evento
    2009-06-10
  • Fecha de publicación del evento
    2009-09-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83675
  • 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
    Implant, cochlear - Product Code MCM
  • Causa
    The recall was initiated after advanced bionics became aware of fourteen (14) devices manufactured between may 27, 2005 and june 30, 2005 that are confirmed to have or potentially have an issue related to the internal magnet. these devices are were made with an internal magnet where the metal case surrounding the magnet was not properly welded. patients with these devices may experience a decreas.
  • Acción
    Advanced Bionics, LLC issued an "Important Notification" dated June 10, 2009 via Fed Ex to Consignees in the US and Canada. Outside of the US, the notification letters will be distributed in such a manner that delivery confirmation can be obtained. There were three type of notification letters distributed: one for Patients, one for Surgeons and one for Clinicians. Letters described the affected device prompting users on what to do next. An acknowledgement form was enclosed and should be completed and sent via fax to 1-661-362-7621. For further information, contact Advanced Bionics at 1-877-829-0026.

Device

Device Recall Harmony HiResolution Bionic Ear system
  • Modelo / Serial
    Serial Numbers: 225271, 301184, 225466, 225647, 225289, 225187, 300922, 225629, 225512, 301129, 300926, 225272, 225373, 300980, 225281, 225423, 225540 and 301027.
  • Clasificación del producto
    Ear, Nose, and Throat Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- US, Canada, France and South Korea.
  • Descripción del producto
    Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. || Cochlear implant intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
  • Manufacturer
    Advanced Bionics LLC

Manufacturer

Advanced Bionics LLC
  • Dirección del fabricante
    Advanced Bionics LLC, 12740 San Fernando Rd, Sylmar CA 91342-3728
  • Empresa matriz del fabricante (2017)
    Sonova Holding Ag
  • Source
    USFDA