Events

Retiro De Equipo (Recall) de syngo Dynamics software version v9.5 using Sensis Integration (Radiology picture archiving and communication system)

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-00287-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-03-07
  • 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-00287-1
  • 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
    A software error could allow for two different patients to be displayed in syngo dynamics where, images shown for one patient and reporting system data (worksheet and/or report) shown for a different patient potentially resulting in misdiagnosis due to mix-up in patient data. when this error occurs, a previously opened study is not properly disconnected from the sensis hemodynamics system. only customers using sensis-syngo dynamics integration will face the occasional probability of this error occurring.
  • Acción
    demographics to review the image toolbar and reporting system, and to ensure that toolbar "auto-hide" is disabled. If a patient mismatch is observed, users are advised to close and reopen the study. A software update will be implemented as a corrective measure. This action has been closed-out on 29/01/2016.

Device

syngo Dynamics software version v9.5 using Sensis Integration (Radiology picture archiving and co...
  • Modelo / Serial
    syngo Dynamics software version v9.5 using Sensis Integration (Radiology picture archiving and communication system)ARTG Number: 120332
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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