Events

Retiro De Equipo (Recall) de MultiDiagnost Eleva II/TV Systems

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-00069-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-29
  • 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-00069-1
  • 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 through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 cfr 1003.2(b)(1). in the md eleva system, software license keys are used to enable particular functionality. in software release r6.1.1sp2 and r6.1.2 intermittently part of the software keys are not loaded: - the license key for spectral filter- the license key for full table tilt range.
  • Acción
    Philips is providing end users with instruction on how to identify if the drivers are not loading correctly. A Philips Field Service Engineer will install a software update to correct this issue. This action has been closed-out on 31/05/2016.

Device

MultiDiagnost Eleva II/TV Systems

Manufacturer

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