Events

Retiro De Equipo (Recall) de Braun wheelchair lift, model NVL,

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 The Braun 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
    56686
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2469-2010
  • Fecha de inicio del evento
    2007-08-15
  • Fecha de publicación del evento
    2010-09-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94280
  • 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
    elevator, wheelchair - Product Code ING
  • Causa
    The wheelchair lifts threshold warning system may not operate and the wheelchair user can fall from the vehicle and be seriously injured.
  • Acción
    The Braun Corporation issued a Service Bulletin 34273 entitled "Lift Threshold Sensitivity Bulletin 34273 on October 2007. Braun Corporation also sent a "Safety Recall" letter to the Braun lift owner and letters to all customers on or about August 15, 2007. The letters described the product, problem and the action to be taken by the customer. The customers were instructed to notify the National Highway Traffic Safety Administration (NHTSA) and conduct a safety recall if they used recalled lifts as original equipment in a system or vehicle that they built; ensure that any associated customers are notified to discontinue the use of their vehicles until they schedule a repair, and verify the threshold warning system is within the NHTSA specification. The customers were informed to contact the NHTSA with questions by calling the Vehicle Safety Hotline at 1-888-327-4236 or go to http//www.safercar.gov. If they have any problem obtaining the needed repair or wish to schedule service with an approved Braun technician, contact the Braun Corporation Product Support at 1-800-946-7513.

Device

Braun wheelchair lift, model NVL,
  • Modelo / Serial
    model year 2005-2006.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution
  • Descripción del producto
    Braun wheelchair lift, model NVL, Braun Corporation, Winamac, IN || A wheelchair lift for motor vehicles.
  • Manufacturer
    The Braun Corporation

Manufacturer

The Braun Corporation
  • Dirección del fabricante
    The Braun Corporation, 631 W 11th St, Winamac IN 46996-1245
  • Empresa matriz del fabricante (2017)
    Investor AB
  • Source
    USFDA