Events

Retiro De Equipo (Recall) de POWER WHEELCHAIR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada 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
    43878
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-06-08
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    The post fuse assemblies on the affected models of invacare power wheelchairs could potentially be defective in a manner that would result in the fuse not operating as intended (blowing) in the event of future damage or faults within the main wiring harness. while each battery is equipped with a fuse that alone would provide the intended safety function there is a potential risk of fire and serious injury should both fuses be defective.

Device

POWER WHEELCHAIR
  • Modelo / Serial
    Model Catalog: TDXSR-MCG (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSR-CG-HD (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSR-CG (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FDX-MCG (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FDX-CG (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FDX (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSR (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSPBASE (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSP (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSP-MCG-GT (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSP-MCG (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSP-CG-GT (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSP-CG (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N/A (Lot serial: )
  • Descripción del producto
    INVACARE POWER WHEELCHAIR
  • Manufacturer
    INVACARE CORPORATION

Manufacturer

INVACARE CORPORATION