Events

Retiro De Equipo (Recall) de Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ 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 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-00595-1
  • Clase de Riesgo del Evento
    Class I
  • 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-00595-1
  • 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 healthcare received complaints that when repositioning the virtual touch iq region of interest from the original (default) location, the lateral position of the measurement tool may not align with the lateral position of the shear velocity data. the maximum error in position between the measurement tool and shear velocity data is 3.8 mm. the issue of concern is a potential underestimation of maximum shear wave velocity of a lesion. this underestimation may lead to a user deciding not to biopsy a cancerous lesion. the potential risk of misdiagnosis associated with this issue is low.
  • Acción
    Siemens Healthcare is requesting the customers not reposition the Virtual Touch IQ region of interest from the original (default) location. Siemens is also requesting the customers to review previously performed studies to ensure the results are as expected. This issue will be resolved in a future software release. This action has been closed-out on 01/03/2018.

Device

Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ option
  • Modelo / Serial
    Acuson S2000 and Acuson S3000 Ultrasound Systems with the Virtual Touch IQ optionARTG Number: 137563
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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