Events

Retiro De Equipo (Recall) de ACUSON SC2000 Ultrasound Systems with Software Version 3.5 (VA35)

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-00539-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-13
  • 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-00539-1
  • 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
    The following issues may occur with cardiovascular studies after upgrading from software version 2.0 or 3.0 to software version 3.5 and restoring user-defined presets. this applies to all transducers except the 9l4 and 6c1 hd transducers:- the system may incorrectly display the colour flow data in the wrong position. the potential risk to the patient is misdiagnosis based on erroneous color flow data.The following issue may occur with software version 3.5:- when you adjust the doppler frequency, the system does not restart the pulsed wave doppler or continuous wave doppler waveform. however, the system displays previous doppler data using the new doppler scale which may result in inaccurate measurement values. the potential risk to the patient is misdiagnosis based on the same doppler profile providing two different velocity measurement values.
  • Acción
    Siemens is advising their customers to use factory default presets with software version 3.5 instead of user defined presets restored from software version 2.0 or 3.0. After adjusting the Doppler frequency, freeze and un-freeze the system to refresh the display of the Doppler spectrum resulting in the correct measurements. Siemens will be replacing the software of all affected devices. Thia action has been closed-out on 28/01/2016

Device

ACUSON SC2000 Ultrasound Systems with Software Version 3.5 (VA35)
  • Modelo / Serial
    ACUSON SC2000 Ultrasound Systems with Software Version 3.5 (VA35)Catalogue Number: 10433816ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

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