Events

Retiro De Equipo (Recall) de Philips Model AFFINITI 50 Ultrasound System (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-00411-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-14
  • 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-00411-1
  • 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 affiniti 50 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). when using both height and weight to calculate the bsa, which is the usual practice for patients above the age of 2 years, the result may be too high by a factor of about 10, an error that would be readily identified by the user. using patient’s weight only to calculate the bsa 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.
  • Acción
    Philips has corrected this issue in software version 1.0.3. which will be provided to users free of charge. Philips has provided work around instructions until the software is implemented. This action has been closed-out on 05/09/2016.

Device

Philips Model AFFINITI 50 Ultrasound System (Intended for diagnostic ultrasound imaging and fluid...
  • Modelo / Serial
    Philips Model AFFINITI 50 Ultrasound System (Intended for diagnostic ultrasound imaging and fluid flow analysis)Software Versions 1.0.2 or lower ARTG Number: 93851
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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