Events

Retiro De Equipo (Recall) de Device Recall Rascal 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 Electric Mobility Corp.

¿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
    37880
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0175-2008
  • Fecha de inicio del evento
    2007-03-29
  • Fecha de publicación del evento
    2007-11-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52042
  • 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
    Powerchair Motorized Vehicles - Product Code INI
  • Causa
    Seat and/or lift actuator problems: 1) models equipped with a seat lift, the mast screw and washer holding the seat lift actuator in place will loosen break off or fall out; 2) models assembled with seat lift actuator or seat post mounting bolts, the seat may wobble or the seat will break off from the vehicle; 3) models using seat-on lifting brackets with a hoist to raise an emc vehicle equipped w.
  • Acción
    Consumers were sent an Urgent Medical Device Recall Notification on October 12, 2007, requesting that they immediately respond to the Medical Device Recall by calling EMC at 1-800-814-4365, or by returning an enclosed Recall Response Form, or by responding on-line at www.EMCIT.NET/801B. The Notification address three important safety issues on 1) Seat Lift Actuator Mast Screws and Washers; 2) Seat Lift Actuator or Seat Post Mounting Bolts and; 3) Incorrect Seat-On Lift Bracket Installation. Corrections to the devices will be made by the nearest Service Representatives, by scheduled in-home repairs, or return of the rear section of the scooter with EMC providing shipping material and freight payment.

Device

Device Recall Rascal Scooter
  • Modelo / Serial
    All serial numbers
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide: to consumers via direct purchase from Electric Mobility Corporation.
  • Descripción del producto
    Rascal Scooters with Electric seat lifts, Model 600 Series, distributed between 10/27/2005 - 3/31/2006, Electric Mobility Corporation (EMC), Sewell, New Jersey 08080
  • Manufacturer
    Electric Mobility Corp

Manufacturer

Electric Mobility Corp
  • Dirección del fabricante
    Electric Mobility Corp, 599 Mantua Boulevard, One Mobility Plaza, Sewell NJ 08080
  • Source
    USFDA