Events

Retiro De Equipo (Recall) de Brilliance iCT with Software Version 4.1.0.19260

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-2013-RN-01333-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-18
  • 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-2013-RN-01333-1
  • 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 has detected a situation where ring artifacts may occur. the conditions that may create these specific ring artifacts occur when a user:1. selects a non-gated helical scan with automatic scan time on 2. they edit the preview images using ‘edit before final recon’ (reconstruction); and,3. the automatic scan time algorithm is executed after the scan has been acquired.Presence of ring artifacts affecting diagnostic quality of images may result in a rescan.
  • Acción
    To avoid the occurrence of these specific ring artifacts users can implement the following work around: 1. Disable Automatic Scan Time for all Exam Cards 2. Leave Automatic Scan Time on during planning and prior to clicking 'Go' to initiate the scan, click the acquisition series of the scan and disable Automatic Scan Time, then proceed with the scan. 3. Disable Edit Before Final Reconstruction for all Exam Cards. If ring artifact is present clinical judgement should be used to determine if rescan is required. A software update will be implemented to correct the problem.

Device

Brilliance iCT with Software Version 4.1.0.19260

Manufacturer

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