Events

Retiro De Equipo (Recall) de SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic 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-01433-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-03
  • 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-2016-RN-01433-1
  • 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 small light marker window used for the positioning laser and integrated in the front cover of the ct that had loosened in the past and had been subsequently fixed, could now become loose again and potentially drop out. in this case, there is a risk that a person could touch rotating or electrical parts of the gantry when reaching through the window opening. there is a risk for serious injury e.G. by electrical shock or physical harm to fingers.
  • Acción
    Siemens is developing a solution for the problem and this will be implemented as a permanent correction. In the interim, users should maintain awareness until a solution is implemented. They should not use the CT system in case a light marker window is missing or loose and is advised to inform the Siemens Service immediately.

Device

SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)
  • Modelo / Serial
    SOMATOM Definition AS and SOMATOM Definition Flash (Computed tomography x-ray diagnostic system)Catalogue Numbers: 8098027, 10430603ARTG Number: 274034
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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