Events

Retiro De Equipo (Recall) de Rascal LiteWay Scooter Model 224

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
    56978
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0416-2011
  • Fecha de publicación del evento
    2010-11-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95193
  • 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
    Vehicle, motorized 3-wheeled - Product Code INI
  • Causa
    Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. this may result in complete failure of the seat base, causing the user to fall off the vehicle.
  • Acción
    The Rascal Company (Electric Mobility Corporation) sent Urgent Medical Device Recall Notice Scooter Seat Base letters dated October 7, 2010 and November 11, 2010 letter to their affected retail customers and affected dealers. The letter instructs the reader that the seat base may become loose, causing the seat to wobble and if not replaced the wobble could lead to a complete failure of the seat base and cause an individual to fall off their vehicle and become injured. The letters also instruct the reader to replace seat bases immediately. Respone forms are attached. Seats with new seat bases will be shipped with return shipping labels to return the original base to the factory. Service representatives will replace the seat base for customers. Customers can contact the Rascal Company about this recall at 1-800-662-4548.

Device

Rascal LiteWay Scooter Model 224
  • Modelo / Serial
    No expiration date; 510 K - K002616; Device Listing #E394292; LW224, EMC Part #43062300, EMC Part #43062700
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: Throughout the US and Canada
  • Descripción del producto
    Rascal LiteWay 224 manufactured by Giant Manufacturing, Taiwan.
  • 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