Events

Retiro De Equipo (Recall) de SOMATOM Definition AS, Definition, Definition Edge, Definition Flash and SOMATOM Force

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-01355-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-11-08
  • 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-01355-1
  • 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
    Siemens has identified a potential risk of unnecessary radiation exposure due to a software issue in the care dose4d algorithm implemented in specific siemens ct scanners. this relates to possible incorrect tube current calculations by the care dose4d algorithm for head scans based on p.A. (posterior-anterior) or a.P. topograms. depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate. potentially, the care dose4d software will select the maximum tube current for the uppermost part of the skull, thus leading to unnecessary radiation exposure. the described issue will not occur when using a lateral topogram instead of a p.A. or an a.P. topogram. accordingly, siemens strongly recommends using topograms in lateral position for all head scans.
  • Acción
    Siemens is advising users that the described issue will not occur when using a lateral topogram instead of a.p.a. or an a.p. topogram. Accordingly, Siemens strongly recommends using topograms in lateral position for all head scans. Siemens will be providing a software update as a permanent correction.

Device

SOMATOM Definition AS, Definition, Definition Edge, Definition Flash and SOMATOM Force
  • Modelo / Serial
    SOMATOM Definition AS, Definition, Definition Edge, Definition Flash and SOMATOM ForceCatalogue Numbers: 7740769, 8098027, 10590000, 10430603 and 10742326ARTG Number: 274034
  • Clasificación del producto
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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