Events

Retiro De Equipo (Recall) de ACUSON SC2000 ultrasound systems with software versions VB10A, VB10B, VB10D, VB10E that have PRIME and eSie PISA software licenses

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-2018-RN-00115-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-02-06
  • 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-2018-RN-00115-1
  • 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 3d esie pisa volume analysis application quantifies valvular regurgitation. while imaging with the z6ms volume transesophageal echocardiography transducer, this application may underestimate the eroa (effective regurgitant orifice area) in comparison to the same patient results obtained with the 4z1c volume transthoracic echocardiography transducer.There is a low risk of misdiagnosis occurring from underestimating the patient's mitral regurgitation severity when using the esie pisa analysis application with the z6ms volume transesophageal echocardiography transducer.
  • Acción
    Siemens is advising that users should continue to rely on a combination of several quantitative parameters for evaluation of mitral regurgitation rather than solely on the EROA derived from eSie PISA analysis with the Z6Ms transducer.

Device

ACUSON SC2000 ultrasound systems with software versions VB10A, VB10B, VB10D, VB10E that have PRIM...
  • Modelo / Serial
    ACUSON SC2000 ultrasound systems with software versions VB10A, VB10B, VB10D, VB10E that have PRIME and eSie PISA software licensesCatalogue Number:10433816ARTG Number:139591
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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