Events

Retiro De Equipo (Recall) de QUBE COMPACT MONITOR

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

¿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
    17967
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-10-24
  • 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
    Potential failure of the qube compact monitor where the input power can fail even though the power source at the wall has not been interrupted. the monitor automatically goes into battery mode and functions normally including the low battery alerts until the batteries become depleted and the monitor turns off. no one has been injured as a result of this issue. in addition there is the potential for the qube compact monitor to fail to turn on. no one had been injured as a result of this issue.

Device

QUBE COMPACT MONITOR
  • Modelo / Serial
    Model Catalog: 91390 (Lot serial: >10 lot numbers contact manf.)
  • Descripción del producto
    Qube Compact Patient Monitor
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

SPACELABS HEALTHCARE (CANADA) INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    OSI Systems Inc
  • Source
    HC