Retiro De Equipo (Recall) de Invacare Storm TDX SR Power Wheelchair with Stability Lock

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Powered wheelchair - Product Code ITI
  • Causa
    For some invacare chairs, the stability lock feature may not be engaging properly or consistently. if the stability lock feature does not engage properly, the wheelchair may do one or more of the following: (1) veer to one side; (2) rock forward onto its front riggings; (3) drive in an unintended circular motion; and/or (4) fall forward or to one side. in these cases there is a risk to injury for.
  • Acción
    On 9/15/2009 the firm sent recall notification letter to their customers instructing them to immediately contact the dealer to have the stability lock inspected and/or adjusted. If the dealer is unavailable or the repair will take longer than 60 days, they are to contact the firm and arrange for an inspection and/or adjustment. Invacare requested contact names to whom it can send additional information. Invacare plans to mail, via FEDEX, information regarding the recall to each consignee. Initial consignees received a response card and instructions to forward cards to any customer to whom they have distributed the product. The products are to be inspected at the cylinder label and if the label does not have a long alpha-numeric string demonstrated in the label, the cylinders on the chair have to be replaced. Questions are directed to or to 800-333-6900.


  • Modelo / Serial
    Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD. Serial Numbers: 08BE000082; 08BE000088; 08BE000089; 08BE000090; 08BE000323; 08BE001102; 08BE001105; 08BE002283; 08BE002803; 08BE003025; 08BE003250; 08BE003251; 08BE003472; 08BE003473; 08BE003632; 08BE004402; 08BE004414; 08BE004415; 08BE004835; 08BE005297; 08DE002040; 08EE000277; 08EE001539; 08EE001540; 08EE001775; 08FE003254; 08FE003257; 08FE003668; 08FE004681; 08GE003570; 08GE003936; 08HE001169; 08HE005013; 08IE001081; 08IE001316 & 08IE002729.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Product was distributed to the following states: AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, MA, ME, MI, MN, MO, MS, NC, ND, NM, NY, OH, SC & TX. Product was also distributed in Canada.
  • Descripción del producto
    Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCG-HD, TDXSRV-HD
  • Manufacturer


  • Dirección del fabricante
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-4190
  • Empresa matriz del fabricante (2017)
  • Source