Events

Retiro De Equipo (Recall) de Brilliance 64 system with software version 4.00xx516 and Ingenuity CT system running software version 4.00xx518 (full body CT 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-2012-RN-01187-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-23
  • 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-2012-RN-01187-1
  • 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. during an interventional procedure with an interventional exam card reconstruction increment set to a negative value, one exposure of cct was not reconstructed – there was radiation but images were not updated on the screen. 2. when moving the couch using the gantry buttons during an interventional procedure & the user chooses an interventional exam card with the reconstruction increment set to a negative value, the user has to wait a few seconds for the new position to update. there is an image update delay at about 5 second intervals. 3. when reconstructing images with o-mar the system may fail to provide a non-omar set of images as required. the non-omar images must be manually reconstructed. 4. the rotor begins to spin without waiting for service personnel to request the go command. 5. incorrect cbv values in the brain perfusion application may occur if the user takes brain perfusion images from a ge scanner into a specific application installed on a philips scanner.
  • Acción
    Philips is provided work around instructions for the issue and will be implementing a software update to correct the problem.

Device

Brilliance 64 system with software version 4.00xx516 and Ingenuity CT system running software ver...
  • Modelo / Serial
    Brilliance 64 system with software version 4.00xx516 and Ingenuity CT system running software version 4.00xx518 (full body CT systems)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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