Events

Retiro De Equipo (Recall) de ACUSON S1000, ACUSON S2000, or ACUSON S3000 Ultrasound Systems with software version VC30A, VC30B, VC30C, or VC31A

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-00599-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-03
  • 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-2015-RN-00599-1
  • 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 recently discovered a potential miscalculation when using the doppler manual trace measurement tool in a full screen display format. the manual trace tool may incorrectly calculate the time average velocity (tav) and subsequently incorrectly calculate the pulsatility index (pi). the potential risk is a misdiagnosis however, the probability is low.
  • Acción
    This issue will be resolved in a future software release. In the interim to avoid this issue, users are advised not to perform measurements utilising the manual Doppler trace tool in a full screen display format. This action has been closed-out on 15/02/2017.

Device

ACUSON S1000, ACUSON S2000, or ACUSON S3000 Ultrasound Systems with software version VC30A, VC30B...
  • Modelo / Serial
    ACUSON S1000, ACUSON S2000, or ACUSON S3000 Ultrasound Systems with software version VC30A, VC30B, VC30C, or VC31AARTG Number: 137563
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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