Events

Retiro De Equipo (Recall) de Permobil Chairman 2K powered wheelchair

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 Permobile 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
    25733
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0834-03
  • Fecha de inicio del evento
    2003-03-07
  • Fecha de publicación del evento
    2003-05-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-06-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26388
  • 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
    Wheelchair, Powered - Product Code ITI
  • Causa
    One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair.
  • Acción
    Permobil Inc has notified its field representatives of the voluntary recall and these representatives have been provided with lists of each Chairman 2K serial number and the Dealer to which the wheelchair was sold. This list also includes the name of the individual for whom the wheelchair was specified at the time of order from Permobil Inc, where applicable. The Permobil field representatives have been trained to perform the upgrade and have been provided the necessary tools to complete the task. They will also train and supervise the Dealer''s technicians who will effect the upgrade at the Dealer level, as the field representatives will rely upon their Dealer network to complete the upgrades in a timely fashion.

Device

Permobil Chairman 2K powered wheelchair
  • Modelo / Serial
    Serial numbers: 1100155 to 1102472 and 4100019 through 4100225.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Canada and Puerto Rico
  • Descripción del producto
    Permobil Chairman 2K powered wheelchair
  • Manufacturer
    Permobile Inc.

Manufacturer

Permobile Inc.
  • Dirección del fabricante
    Permobile Inc., 6961 Eastgate Blvd, Lebanon TN 370906005
  • Source
    USFDA