Events

Retiro De Equipo (Recall) de SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray 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-01461-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-09
  • 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-01461-1
  • 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
    Customers with software version va50_sp2 will be provided an update to software version va50_sp3. the installation of this update will address software bugs that were identified through field monitoring. some of the major bug fixes that will be addressed with this software are:1) correction to volumetric misrepresentations of high contrast objects when using admire.2) correction to highly sporadic scan aborts due to temporarily tube currents at 0ma.3) correction to missing microsoft hotfixes (ms16-001, ms15-135, ms15-088, ms15-048). 4) correction to highly sporadic image artefacts caused by error signals from high voltage chain at extremely high tube currents.5) correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed.6) correction to highly sporadic scan aborts due to temporarily high disk load of system disk.7) correction to highly sporadic image artefacts generated by scatter correction in case of tube arcing.
  • Acción
    Customers are advised that the update will be remotely pushed to the system or Siemens will contact customers to arrange a date for the installation of the software update onsite.

Device

SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray system)
  • Modelo / Serial
    SOMATOM Force with software version VA50_SP2 (Computed tomography x-ray system)ARTG Number : 274034
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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