Events

Retiro De Equipo (Recall) de Device Recall Padded, swingaway armrests on Quickie Q7, GT, GTi and Zippie Zone wheelchairs

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 (US) LLC.

¿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
    62493
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2113-2012
  • Fecha de inicio del evento
    2012-06-26
  • Fecha de publicación del evento
    2012-07-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110756
  • 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, mechanical - Product Code IOR
  • Causa
    Reports of injury when the padded swing away armrest is used for full body weight. owner's manual states that armrest is only designed for resting of forearm.
  • Acción
    Sunrise Medical sent a Safety Notice letter dated June 25, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter request that clinicians/suppliers post this safety notice in a conspicuous location, making customers and therapists aware of the issue. The letter also encourage end users to read the owner's manual and follow the recommenations for proper usage of the recalled product. Customers are instructed to complete and return the Supplier Notification and Response Form. For questions contact Sunrise Medical Regulatory Affairs at 888-208-4901.

Device

Device Recall Padded, swingaway armrests on Quickie Q7, GT, GTi and Zippie Zone wheelchairs
  • Modelo / Serial
    Receiver Product number 109207.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and the countries of Argentina, Brazil, Columbia, Costa Rica, Mexico, Panama, Uruguay and Venezuela.
  • Descripción del producto
    Padded Swing Away Arm Rest with Receiver; || Uses on wheelchair models: || Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). || Product Usage: || To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions.
  • Manufacturer
    Sunrise Medical (US) LLC

Manufacturer

Sunrise Medical (US) LLC
  • Dirección del fabricante
    Sunrise Medical (US) LLC, 2842 N Business Park Ave, Fresno CA 93727-1328
  • Empresa matriz del fabricante (2017)
    Sunrise Medical (Us) Llc
  • Source
    USFDA