Retiro De Equipo (Recall) de Philips IntelliVue Patient Monitors and Philips Avalon Fetal MonitorsIntelliVue Patient Monitors, software versions J.21.03 & J.21.19

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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 I
  • 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
    In time-synchronized automatic/sequence mode the noninvasive blood pressure (nbp) automatic measurement series is stopped inadvertently, if the repetition interval is increased manually by the user (e.G. from 5 to 15 minutes) in between two consecutive measurements.- a prompt message “any ongoing nbp measurement and automatic cycle stopped” is displayed and a single tone sounds when the measurement series is stopped.- after the automated measurement series has been stopped, nbp numeric, repetition time, and time to next measurement are no longer displayed, i.E. the nbp numeric field is blank.If the nbp measurement is stopped, and a patient’s blood pressure is not being monitored, a delay in treatment could occur.
  • Acción
    A Philips Healthcare representative will contact customers with affected devices to arrange a software upgrade to correct the issues. During the interim period until the SW is upgraded, customers are advised to make sure, if the NBP repetition interval needs to be increased (e.g. from 5 to 15 minutes), to restart the automatic NBP measurement. This action has been closed-out on 12/08/2016.


  • Modelo / Serial
    Philips IntelliVue Patient Monitors and Philips Avalon Fetal MonitorsIntelliVue Patient Monitors, software versions J.21.03 & J.21.19Models and Product Numbers: MP5 (M8105A), MP5SC (M8105AS), MP5T (M8105AT), MP5 Upgrade (M8105AU), MP5SC Upgrade (866327)ARTG Number: 94238Avalon Fetal Monitors, software version J.30.58Models and Product Numbers: FM20 (M2702A), FM30 (M2703A), FM50 (M2705A)ARTG Number: 99202
  • Clasificación del producto
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source