Events

Retiro De Equipo (Recall) de Philips Model EPIQ 7 Ultrasound System with Pediatric Cardiology option(Intended for diagnostic ultrasound imaging and fluid flow analysis)

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-00407-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-15
  • 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-00407-1
  • 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 epiq 7 ultrasound system is set up to ‘metric’ and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patient’s body surface area (bsa). using patient’s weight only to calculate the bsa, which is the usual practice for patients under the age of 2 years, would result in a value that is too high by a factor of about 1.7. a cardiac index calculated using that value would be too low by a factor of 1.7. an error of this magnitude may not be readily detected by the user.Alternatively, when using weight only the bsa may be out by a factor of about 1.7 which is much harder to detect as a cardiac index calculated using that value may not be as obvious to the user. however it is highly unlikely that this type of calculation would be used for patients older than 2 years of age. therefore, the risk of this error occurring is greatest when the bsa is calculated using weight only in patients under 2 years of age.
  • Acción
    Philips has corrected this issue in software version 1.3.3. which will be provided to users free of charge. This action has been closed-out on 15/08/2016.

Device

Philips Model EPIQ 7 Ultrasound System with Pediatric Cardiology option(Intended for diagnostic u...
  • Modelo / Serial
    Philips Model EPIQ 7 Ultrasound System with Pediatric Cardiology option(Intended for diagnostic ultrasound imaging and fluid flow analysis)Software versions 1.3.2 or lower ARTG Number: 93851
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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