Events

Retiro De Equipo (Recall) de Biograph mCT and Biograph mCT Flow systems running VG50A software and equipped with the Adaptive 3D Intervention option

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens 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-2014-RN-01243-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-11-21
  • 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-2014-RN-01243-1
  • 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
    Siemens has identified a potential malfunction that may cause a display freeze during ct interventional procedures. the user interface may lock-up when performing an adaptive 3d interventional procedure when the "auto save at last displayed images as key images" is enabled. when the issue occurs, normal interaction with the system is no longer possible and no error messages are displayed. therefore the end-user and/or interventionalist may not know that the system has stopped interacting and continue wiht the interventional procedure.
  • Acción
    Siemens is advising their customers to reconfigure the system Storage to deactivate "Auto save at last displayed images as key images". A software update will be implemented to correct the problem. This action has been closed-out on 18/03/2016.

Device

Biograph mCT and Biograph mCT Flow systems running VG50A software and equipped with the Adaptive ...
  • Modelo / Serial
    Biograph mCT and Biograph mCT Flow systems running VG50A software and equipped with the Adaptive 3D Intervention optionSoftware version: VG50AARTG number: 144218
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA