Events

Retiro De Equipo (Recall) de SOMATOM Force with software version VA50A

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-2017-RN-00487-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-19
  • 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-2017-RN-00487-1
  • 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
    An addendum is to be added to the instructions for use (ifu) of the somatom force system with software version va50a which is related to the use of the turbo flash mode with very short scan ranges. when selecting the turbo flash mode in combination with a spiral scan length of less than 27 mm the image reconstruction will possibly fail for this scan. as a workaround the addendum states for the turbo flash mode to always select a spiral scan length higher than 27 mm or to switch to another mode instead.
  • Acción
    Siemens is advising users to always select a spiral scan length higher than 27mm or to switch to another mode when selecting the Turbo Flash Mode in combination with a spiral scan length of less than 27mm. (This information is contained in the addendum which will be posted to users). Users are requested to place this addendum in their User Manual and to disseminate the information to the relevant personnel at their organisation.

Device

SOMATOM Force with software version VA50A
  • Modelo / Serial
    SOMATOM Force with software version VA50ACatalogue Number: 10742326ARTG Number: 274034
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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