Retiro De Equipo (Recall) de ACUSON SC2000 ultrasound systems with software versions VA16A to VA30A and the Stress Echo 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 Healthcare Pty 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-00720-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-12
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    When performing a 2d stress echo study, specific keystrokes may result in a potential loss of data, where some selected clips may not be saved as part of the study. the potential risk is that the stress echo study may need to be performed again.
  • Acción
    Siemens is providing users with interim instructions to follow. A software update will be provided to affected users, which will resolve the issue. This action has been closed-out on 05/12/2016.

Device

  • Modelo / Serial
    ACUSON SC2000 ultrasound systems with software versions VA16A to VA30A and the Stress Echo OptionCatalogue/Lot number – 10433816 (ACUSON SC2000) with software versions VA16A to VA30A and 10436375 (2D Stress Echo Licence)ARTG number: 139591
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA