Events

Retiro De Equipo (Recall) de EPIQ5 Vi .0.x/1 .1 .x with QLAB a2DQ and/or aCMQ plug-ins

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-01253-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-11-27
  • 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-01253-1
  • 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
    When using the epiq5 ultrasound system with qlab auto 2d quantification (a2dq) and auto cardiac motion description quantification (acmq) applications to calculate end-systolic volume (esv), the reported esv may be smaller than esv calculated by manual tracing without the use of epiq5 ultrasound system with qlab. correspondingly, the left ventricular ejection fraction (ef) calculated using these applications may be higher than the ef calculated by manual tracing without the use of epiq5 ultrasound system with qlab. philips’ investigation has found that this difference may occur in cases where the ef is less than approximately 40%.
  • Acción
    Philips is providing instructions to assist end users to determine if they are affected by this issue. Philips has developed a software update to correct the issue. A CD with the new version of the software will be sent to all end users for installation. Until the software has been upgraded, the issue can be avoided by ensuring that left ventricular volumes and ejection fraction are calculated by using either the on-cart manual analysis package or off-cart manual analysis package for your primary assessment. This action has been closed-out on 05/08/2016.

Device

EPIQ5 Vi .0.x/1 .1 .x with QLAB a2DQ and/or aCMQ plug-ins

Manufacturer

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