Events

Retiro De Equipo (Recall) de STORM SERIES 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
    30202
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-01-09
  • 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
    Invacare has recently identified a potential wiring pinch point involving invacare fdx tdx series and storm series power wheelchairs with 20"-24" width configurations with formula cg recline seating system (i.E. tilt/recline tilt/recline/elevate or recline only) and a conventional style back. there is a possibility that if the slack in the wires is not routed and secured correctly and with flexing of the back pan under the user's weight the headrest knob or clamp bracket may pinch damage or cut the wire creating a hazard. smoking sparking burning or fire may occur if any wire in this area is repetitively pinched at the same location over a period of time. not all impacted chairs are expected to have slack in the wiring that is not routed and secured correctly.

Device

STORM SERIES POWER WHEELCHAIR
  • Modelo / Serial
    Model Catalog: 3GTQ3-MCG (Lot serial: CONTACT MFG); Model Catalog: 3GTQ3-CG (Lot serial: CONTACT MFG); Model Catalog: 3GTQ-MCG (Lot serial: CONTACT MFG); Model Catalog: 3GTQ-CG (Lot serial: CONTACT MFG); Model Catalog: 3GSEAT-CG (Lot serial: CONTACT MFG); Model Catalog: 3GRX-CG (Lot serial: CONTACT MFG); Model Catalog: 3GAR-CG (Lot serial: CONTACT MFG); Model Catalog: TDXSRSEAT (Lot serial: CONTACT MFG); Model Catalog: TDXSR-MCG-HD (Lot serial: CONTACT MFG); Model Catalog: TDXSR-MCG (Lot serial: CONTACT MFG); Model Catalog: TDXSR-CG-HD (Lot serial: CONTACT MFG); Model Catalog: TDXSR-CG (Lot serial: CONTACT MFG); Model Catalog: FDX-CG (Lot serial: CONTACT MFG); Model Catalog: TDXSP-MCG-GT (Lot serial: CONTACT MFG); Model Catalog: TDXSP-MCG (Lot serial: CONTACT MFG); Model Catalog: TDXSP-CG-GT (Lot serial: CONTACT MFG); Model Catalog: TDXSP-CG (Lot serial: CONTACT MFG); Model Catalog: FDX-MCG (Lot serial: CONTACT MFG); Model Catalog: TDXSPSEAT (Lot serial: CONTACT MFG)
  • Descripción del producto
    STORM SERIES POWER WHEELCHAIRS
  • Manufacturer
    INVACARE CORPORATION

Manufacturer

INVACARE CORPORATION