Retiro De Equipo (Recall) de NEPTUNE 2 WASTE MANAGEMENT SYSTEM - ROVER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por STRYKER CANADA LP.

¿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
    51369
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2014-01-24
  • País del evento
  • 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 purpose of this correction is to upgrade the neptune 2 waste management system to the new approved specifications. previously stryker had received reports that the neptune 2 had been connected directly to a chest tube postoperatively which resulted in fatalities and injuries. the new approved specifications include a change in technology a control mechanism change as well as a modification to the canister vacuum level regulator [from mechanical to electrical]. the neptune 2 has been re-designed to address the hazards and harms outlined in previously recalls.

Device

Manufacturer

  • Dirección del fabricante
    HAMILTON
  • Empresa matriz del fabricante (2017)
  • Source
    HC