Events

Retiro De Equipo (Recall) de Device Recall Manual Wheelchairs with Transit System Option

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 Sunrise Medical 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
    Recall
  • ID del evento
    51260
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0831-2011
  • Fecha de inicio del evento
    2009-02-02
  • Fecha de publicación del evento
    2010-12-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79491
  • 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
    Mechanical wheelchair - Product Code IOR
  • Causa
    The stabilizer bar was inadvertently omitted during the manufacturing process.
  • Acción
    An Urgent: Medical Device Correction letter, dated February 2009, with certified return receipt was sent to customers in the United States; Canadian consignees were notified via e-mail. The letter identified the affected product and the reason for the recall. The letters asked customers to contact their Quickie dealer to make arrangements to have their device wheelchair corrected at no charge and to also verify their wheelchair serial number on the form. Questions should be directed towards their dealer or Sunrise Medical at 800-456-8168.

Device

Device Recall Manual Wheelchairs with Transit System Option
  • Modelo / Serial
    Serial Numbers:  LXI-034554, LXI-034697, LXI-034694, LXI-034500, LXI-034609, LXI-034740, and  LXI-034741.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States and Canada.
  • Descripción del producto
    Manual Wheelchairs with Transit System Option, || Model: Quickie LXI (EILXI), || Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA || Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat.
  • Manufacturer
    Sunrise Medical Inc

Manufacturer

Sunrise Medical Inc
  • Dirección del fabricante
    Sunrise Medical Inc, 2842 N Business Park Ave, Fresno CA 93727-1328
  • Source
    USFDA