Events

Retiro De Equipo (Recall) de Philips MX 16-slice Computer tomography x-ray system (software upgrade from v2.0.0.21479 to v2.0.0.21480)

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-2015-RN-01082-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-06
  • 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-2015-RN-01082-1
  • 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
    In 2d and filming function, when image is zoomed and saved as derived dicom format, the measurement on new created image is incorrect. this issue only occurs on mx16 systems with software version v2.0.0.21479, including mx16 evo2 systems and mx 16 systems upgraded to mx16 evo2 using the mx16 idose4 upgrade kit.Image with incorrect measurement value may be used to guide clinical procedures where measurement is critical. this may lead to misdiagnosis.
  • Acción
    An initial workaround is provided for users in the Customer Letter. Philips will release Field Change Order (FCO) 72800646 to upgrade the software free of change. A Philips Field Engineer will contact users to schedule this correction. This action has been closed-out on 31/08/2016.

Device

Philips MX 16-slice Computer tomography x-ray system (software upgrade from v2.0.0.21479 to v2.0....
  • Modelo / Serial
    Philips MX 16-slice Computer tomography x-ray system (software upgrade from v2.0.0.21479 to v2.0.0.21480)Affected Products: Philips MX 16-slice CT Systems with software version v2.0.0.21479 ARTG Number: 158775
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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