Events

Retiro De Equipo (Recall) de Philips EPIQ 5 Ultrasound System

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
    Recall
  • ID del evento
    RC-2014-RN-00360-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-25
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00360-1
  • 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
    The epiq 5 will report incorrect doppler velocities if users use high pulse repetition frequency (hprf) with multiple sample volume gates.While in high pulse repetition frequency (hprf) in ‘display zoom velocity scale’ using manual spectral doppler trace, the velocities in the velocity results table may be overstated by 25-75%, depending on the scale value. the erroneous values are reported on the reports page and in dicom sr if exported and include the following velocities and calculations:general imaging, (gi)-- peak systolic velocity (psv)- end diastolic volume (edv)- minimum diastolic velocity (mdv)- time averaged peak velocity (tapv)- time averaged mean velocity (tamv)affected gi calculations:- s/d (ratio of peak systolic velocity / peak diastolic velocity)- resistivity index (ri)- pulsatility index (pi).
  • Acción
    Philips has corrected the issues in software version 1.1.2. Philips is advising their customers to not use HPRF in doppler mode until the affected system is upgraded to version 1.1.2. This action has been closed-out on 12/02/2016.

Device

Philips EPIQ 5 Ultrasound System

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA