Events

Retiro De Equipo (Recall) de Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed Tomography (CT) system)

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-2016-RN-00401-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-04-05
  • 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-2016-RN-00401-1
  • 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 manufacturer has advised that the use of the neonate head protocol with the paediatric kernel hp38 could result in artefacts and possibly lead to misdiagnosis. either not existing blood or liquid is mimicked in the images or actually existing blood or liquid is not depicted as expected. investigations revealed a wrong parameterisation of the reconstruction algorithm applied for the paediatric head kernel as cause of the problem. this does not affect other kernels or reconstruction modes.
  • Acción
    Siemens is advising users not to use the Neonate Head protocol with paediatric kernel Hp38 and is recommending using kernel Hr38 instead. The reconstruction of images is based on raw data, the data acquisition parameters are not affected and no additional dose is applied to the patient. A software upgrade will be performed as a permanent correction. This action has been closed-out on 03/02/2017.

Device

Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed T...
  • Modelo / Serial
    Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed Tomography (CT) system)Catalogue Number: 10742326 ARTG Number: 164065
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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