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-00486-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-29
  • 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-00486-1
  • 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 when using the stress echo feature:- shorter-than-expected clips may occur when using systolic-only captures with heart rates at approximately 120bpm (beats per minute) and higher. this computational error may occur at any heart rate; but the system produces a smaller error for lower heart rates. the issue may also cause the system to change from systolic-only captures to full beat (r-r).- intermittently, some post-exercise clips may not be captured during continuous capture acquisition. - post-exercise clips marked for deletion (unselected clips) may be restored to the study after cycling power to the system. the potential risk to the patient may be a repeated stress echo study.
  • Acción
    A software update will be provided to correct this problem. End users are advised to avoid the potential risks associated with this issue by: - Discontinue use of the stress echo feature with software version 3.5 - For studies acquired with the systolic only captures, review all patient studies on exams performed after the software revision 3.5 was installed.

Device

ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)
  • Modelo / Serial
    ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)ARTG Number: 139591
  • Manufacturer
    Siemens Ltd

Manufacturer

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