Events

Retiro De Equipo (Recall) de Device Recall TDX SP Power 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 Invacare Corporation.

¿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
    61160
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1201-2012
  • Fecha de inicio del evento
    2012-02-10
  • Fecha de publicación del evento
    2012-03-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107440
  • 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
    Invacare corporation decided to recall the product because use of this actuator could result in reduced cross sectional current carrying area due to wear/chafing of the wires.
  • Acción
    The firm, Invacare, sent an "URGENT: RECALL INFORMATION" letter dated February 10, 2012 to their consignees/customers. The letter described the product, problem and actions to be taken. Invacare has developed retrofit kits intended to address this issue. The consignees were instructed to contact the customers that have potentially affected product and perform the necessary updates. The consignees were also instructed to complete and return the Provider Response Form to order the retrofit kit. If you have any questions, please contact Customer Service at 1-800-333-6900.

Device

Device Recall TDX SP Power Wheelchair
  • Modelo / Serial
    Model# TDXDP-CG, Serial# 11HE001056; Model# TDXP-CG, Serial# 11GE004364, 11HE000039; Model# TDXSP-CG, Serial# 11GE001580, 11GE001593, 11GE001874, 11GE001886, 11GE001919, 11GE001919, 11GE001920, 11GE002363, 11GE002455, 11GE002456, 11GE002464, 11GE002622, 11GE002625, 11GE002635, 11GE002839, 11GE002850, 11GE003048, 11GE003075, 11GE003249, 11GE003258, 11GE003500, 11GE003503, 11GE003687, 11GE003690, 11GE003931, 11GE003934, 11GE004230, 11GE004354, 11GE004355, 11GE004356, 11GE004359, 11GE004361, 11GE004490, 11GE004638, 11GE004642, 11HE000047, 11HE000333, 11HE000335, 11HE000343, 11HE000344, 11HE000508, 11HE000748, 11HE000749, 11HE000752, 11HE000755, 11HE000848, 11HE001057, 11HE001243, 11HE001244, 11HE001246, 11HE001311, 11HE001515, 11HE001645, 11HE001647, 11HE001653, 11HE001659, 11HE001838, 11HE001843, 11HE00756; Model# TDXSP-CG-GT, Serial# 11GE001891, 11GE002134, 11GE002849, 11GE003064, 11GE003504; Model# TDXSP-CT-GT, Serial# 11GE002849; Model# TDXSP-MCG, Serial# 11GE000322, 11GE001567, 11GE001894, 11GE002136, 11GE002137, 11GE002372, 11GE002376, 11GE002377, 11GE002378, 11GE002382, 11GE002383, 11GE002385, 11GE002657, 11GE002852, 11GE003065, 11GE003067, 11GE003070, 11GE003073, 11GE003252, 11GE003261, 11GE003263, 11GE003266, 11GE003711, 11GE003712, 11GE003938, 11GE004134, 11GE004135, 11GE004368, 11HE000055, 11HE000102, 11HE000348, 11HE000511, 11HE000761, 11HE001250, 11HE001450, 11HE002071 & 11HE002523.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AZ, CA, CT, FL, GA, IA, IL, IN, KY, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, RI, SD, TX, VA, WA, and WI; and countries of: Australia, Canada and New Zeland.
  • Descripción del producto
    TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distributed By: || Invacare Corporation, Elyria, OH 44035 || The Invacare TDX power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or non-folding type power wheelchair, with mid wheel drive capability.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Dirección del fabricante
    Invacare Corporation, 1 Invacare Way, Elyria OH 44035-4190
  • Empresa matriz del fabricante (2017)
    Invacare Corporation
  • Source
    USFDA