Events

Retiro De Equipo (Recall) de Brilliance 64, software version 4.0.0.22621 and Ingenuity CT, software version 4.0.025621 (Whole body computed tomography x-Ray 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-2013-RN-00197-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-03-04
  • 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-00197-1
  • 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
    1- swirl-like ring artifacts may appear on reconstructed images impairing the diagnostic quality.2- when executing two bolus scans the system may freeze during the second tracker execution, impacting countdown timer displayed to the user which indicates the start of the clinical scan. 3- there are inconsistencies between the gui and the instructions for use (ifu)/technical reference guide (trg): english version 459800340361_a documentation for the (qa) testing4- teflon and other pins hu values are incorrectly documented in the ifu/trg.
  • Acción
    Philips is provided information and work around instructions to mitigate some of the issues. A software update and revision of the Instructions for Use (IFU) documentation will be implemented to correct the issue.

Device

Brilliance 64, software version 4.0.0.22621 and Ingenuity CT, software version 4.0.025621 (Whole ...
  • Modelo / Serial
    Brilliance 64, software version 4.0.0.22621 and Ingenuity CT, software version 4.0.025621 (Whole body computed tomography x-Ray systems)ARTG: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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