Retiro De Equipo (Recall) de Device Recall Medline Strider Maxi 3 Scooter

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 Medline Industries 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    scooter - Product Code INI
  • Causa
    Under conditions of heavy use, signs of overheating of the main battery cables have been observed.
  • Acción
    Medline sent 'Voluntary Field Correction' letters dated 7/20/06 to the direct accounts on the same date, informing them that the Strider Maxi 3 and Maxi 4 scooters have main battery cables that may overheat under conditions of heavy use, and that Medline will provide an upgrade kit to replace the battery cables. Any questions were directed to 800-289-9793, press 1, then press 3 and ask to transfer to 4674 (8:00 AM to 5:00 PM CST). Follow-up letters were sent to the distributors and end-users on 10/31/06. The end users were informed of the problem with the scooters, and were requested to call Medline at 800-289-9793, press 1, then press 3 and ask to transfer to 4674 (8:00 AM to 5:00 PM CST) to have the scooter upgraded. The end users were requested to inform the service technician that hey have one of the affected Maxi Scooters, and provide him with their full name, phone number and street address, as well as the name, address and/or phone number of teh store where the Medline Scooter was purchased. Medline will arrange with the dealership or retail store to upgrade the scooter at no cost to the end user.


  • Modelo / Serial
    model MDS807600 - red and model MDS807600B - blue, all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
  • Descripción del producto
    Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kaohsiung, Taiwan for Medline Industries, Inc., One Medline Place, Mundelein, IL 60060 USA; model MDS807600 - red and MDS807600B - blue
  • Manufacturer


  • Dirección del fabricante
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4486
  • Source