Events

Retiro De Equipo (Recall) de Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Computed Tomograph (CT) x-ray system)

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-00417-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-07
  • 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-00417-1
  • 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
    An issue has been found with the ingenuity core128 system with software version 3.5.5. if additional acquisitions/scans are requested prior to completion of the current reconstructions, not all planned images from the current reconstruction are displayed to the user. users may not be aware the information is not lost, as the raw data can be reconstructed off-line displaying all requested reconstructions. if a rescan is required, there is potential for unnecessary radiation.
  • Acción
    Philips is requesting customers to verify that all planned image reconstructions are completed and to perform off-line reconstructions, if expected images are missing. Philips will be installing a software update to correct the issue. This action has been closed-out on 01/02/2016.

Device

Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Computed Tomograph (CT) x-ray s...
  • Modelo / Serial
    Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Computed Tomograph (CT) x-ray system)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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