Events

Retiro De Equipo (Recall) de Philips Brilliance iCT/iCT SP with software version 4.1.3, 4.1.5

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-2016-RN-00680-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-05-26
  • 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-2016-RN-00680-1
  • 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 became aware of certain issues with the affected products through testing & customer feedback. the identified issues include;- imr cardiac - irregular appearance of contrast in vessels;- missing image annotations in cct- halo artefacts- incorrect z annotation on plan box for coronal/sagittal surviews- post injection delay between timed scans may be inaccurate- unintended change of acquisition timing on scan ruler- bolus tracker does not trigger as expected- cardiac step & shoot stops after arrhythmia detected- tracker scan halted with fdom- error when auto roi placement outside patient anatomy- no "go" when hr outside acceptable range- unplanned results during multi-phase pulmo series, may cause a system crash- dynamic myocardial perfusion acquisition halted after 1st shot- double clicking ecg phase bar crashes exam application- incorrect phase tolerance for cardiac s&s; &- ring artefacts on high resolution images, idose4 & imr.
  • Acción
    Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 24/05/2017.

Device

Philips Brilliance iCT/iCT SP with software version 4.1.3, 4.1.5

Manufacturer

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