Events

Retiro De Equipo (Recall) de ACUSON SC2000 ultrasound systems with software versions VB10B and lower

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-00816-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-31
  • 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-00816-1
  • 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 acuson sc2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. the system recalls the case sensitivity even if the original study has been removed from the hard drive. if these differences are not corrected at the time of registration, the system does not capture images or clips.The potential risk is the study data, including measurements, may not be captured and the study will need to be re-performed.
  • Acción
    Siemens is providing work around instructions to follow as an interim measure. A software upgrade will be provided as a permanent solution. This action has been closed-out on 18/04/2017.

Device

ACUSON SC2000 ultrasound systems with software versions VB10B and lower
  • Modelo / Serial
    ACUSON SC2000 ultrasound systems with software versions VB10B and lowerLot number: 10433816ARTG number: 139591
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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