Events

Retiro De Equipo (Recall) de Lumex

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 Graham Field Atlanta.

¿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
    37747
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0772-2007
  • Fecha de inicio del evento
    2007-04-02
  • Fecha de publicación del evento
    2007-05-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51451
  • 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
    Rollator - Product Code ITJ
  • Causa
    The caster bolt stem/screw may loosen over time causing the wheel to come off.
  • Acción
    Graham-Field notified all of its Durable Medical Equipment (DME) dealers involved in the distribution of these products by certified US Mail on April 3, 2007. They were made aware of the need to adjust the product to lessen the risk of injury and were provided a re-work kit. The distribution of DME dealers includes the announcement of the field correction to the DME dealer, the letter to send to the end-users, rework supplies, rework instructions and proof of compliance cards. Graham-Field instructed the DME dealers to adjust any impacted products on site, as well as, any delivered by end-users, customers or other impacted third parties to the DME dealer for correction. DME dealers will be compensated for performing the corrective action. The installation of the rework kit involves the installation of lock washers and Locitite and is described in more detail in the attached rework instructions. Graham-Field does not have direct access to end user names, however it plans to reach end-users by financially supporting a certified mailing from DME dealers to their individual customers notifying them of this field correction. A follow-up 60 day certified mailing will be performed for non-responders.

Device

Lumex
  • Modelo / Serial
    Model numbers: RJ4300B, RJ4300D, RF4300G, RJ4300K, RJ4300R, and Imperial Model RF4400K. (Note: Models distributed after January 2007, serial numbers 120791 through 145254, are not subject to this correction)
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    U.S. Nationwide, Costa Rica, Ecuador, El Salvador, Guatemala, and Santo Domingo
  • Descripción del producto
    Lumex¿ Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360.
  • Manufacturer
    Graham Field Atlanta

Manufacturer

Graham Field Atlanta
  • Dirección del fabricante
    Graham Field Atlanta, 2935 Northeast Pkwy, Atlanta GA 30360-2808
  • Source
    USFDA