Retiro De Equipo (Recall) de DASH, PDM and Tram models (Multiparameter patient monitor) Manufactured between October 2010 and September 2012

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GE Healthcare 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
    Ecg and respiration signal noise caused by dash, pdm and/or tram ecg cable connector movement may result in reduced ecg, respiration and arrhythmia detection performance.
  • Acción
    End users have been provided with work around instructions to help mitigate the issue. GE Healthcare is currently in discussion with TGA as how to best expedite identification of, and prioritised correction of affected units. A follow-up letter will be forwarded once there is a consensus as to the process to be undertaken. This action has been closed-out on 12/02/2016.


  • Modelo / Serial
    DASH, PDM and Tram models (Multiparameter patient monitor) Manufactured between October 2010 and September 2012Dash 3000/4000/5000Product codes: SHQ and SD0Patient Data Module (PDM)Product code: SA3Tram 451, 451N, 451M, 851, 851N, 451N5, 851N5Product codes: RT1, RT4, RT5, RT7, RT8, RTW, SCE and SBBARTG Number: 92726
  • Manufacturer