Events

Retiro De Equipo (Recall) de Philips Ultrasound QLAB versions 10.0 and 10.1

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-00837-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-31
  • 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-00837-1
  • 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
    Philips healthcare has discovered a problem in the philips ultrasound qlab version 10.0 and 10.1 when used on a picture archiving and communication system (pacs) or with third party pacs integration that could result in the erroneous calculation of ejection fraction (ef) from the results of a2dq and acmq patient exams. an incorrect ef calculation could lead to misdiagnosis and/or delayed or incorrect therapy.
  • Acción
    Philips has corrected this issue in QLAB version 10.2, and is sending a CD with QLAB version 10.2 to affected customers. Until your software can be upgraded to QLAB version 10.2, end users can avoid the issue by: - Ensuring that a2DQ patient exams include both biplane views for AP2 and AP4. When both biplane views are present, EF measurements will not persist from measurements taken in a prior patient exam. - Ensuring that aCMQ patient exams include all three views (AP2, AP3, and AP4). When all three views are present, measurements will not persist from measurements taken in a prior patient exam. This action has been closed-out on 03/06/2016.

Device

Philips Ultrasound QLAB versions 10.0 and 10.1
  • Modelo / Serial
    Philips Ultrasound QLAB versions 10.0 and 10.1Part Numbers: 453561704771 and 453561728001ARTG Number: 100468
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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