Retiro De Equipo (Recall) de Stryker Standard Video Cart and Vision Mounting Arm

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia Pty Ltd.

¿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 II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    If the tension screw present in the mounting yoke of the vision mounting arm is loose and the user applies excessive force during positioning, the user can push the monitor out of the yoke. this will cause the monitor to dislodge from the mounting arm and fall potentially impacting an operator or patient.
  • Acción
    Stryker is advising users that a new screw and washer will be installed on all affected units to ensure the monitor is securely fastened to the mounting yoke. It is expected that this will be completed by April 2014.


  • Modelo / Serial
    Stryker Standard Video Cart and Vision Mounting ArmCatalogue Numbers: 0240099011 (Video Cart), 0240099011I (Video Cart), 0240095200 (Mounting Arm) All lots affectedARTG Number: 106511
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source