Events

Retiro De Equipo (Recall) de Philips Ultrasound QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software

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-2015-RN-00335-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-20
  • 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-2015-RN-00335-1
  • 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 qlab auto 2d quantification (a2dq) and auto cardiac motion quantification (acmq) applications to calculate end-systolic volume (esv), the reported esv may be smaller than the esv calculated by manual tracing without the use of 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 qlab. philips’ investigation has found that this difference may occur in cases where the ef is less than approximately 40%.An incorrect ejection fraction calculation could lead to misdiagnosis and/or delayed or incorrect therapy if healthcare providers make clinical decisions based solely on these measurements, without considering other available clinical data.
  • Acción
    Philips is providing temporary work instructions for users to follow until a software upgrade to QLAB Version 10.2 or higher is completed. This action has been closed-out on 12/08/2016.

Device

Philips Ultrasound QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcele...
  • Modelo / Serial
    Philips Ultrasound QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera softwareARTG number: 170658
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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