Events

Retiro De Equipo (Recall) de SOMATOM CT System SOMATOM Definition Flash running software version syngo CT2012B SOMATOM Definition Edge running software version syngo CT2012B SOMATOM Definition AS running software version syngo CT2012B SOMATOM Definition running software version syngo CT2012B SOMATOM Definition AS running software version syngo CT2013

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 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-2013-RN-01317-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-11
  • 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-2013-RN-01317-1
  • 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 software malfunction that may lead to a system display freeze during interventional procedures. if the function, "auto save last displayed images as key images" is activated during an interventional procedure, the software configuration allows conflicting access to the ct system image database. in such situations, a system display freeze might occur. normal interaction with the system is then no longer possible. no error message is issued and only a system restart resolves the problem. in case of a sudden system display freeze the interventionalist will potentially not immediately recognise the malfunction and continue the interventional procedure. there is a possibility of injury to a patient.
  • Acción
    Siemens advising users to deactivate the "Auto save last displayed images as key images" function to prevent the issue from occurring. Images can continue to be saved manually. Siemens is providing a software update to permanently correct the issue in February 2014. This action has been closed-out on 29/01/2016.

Device

SOMATOM CT System SOMATOM Definition Flash running software version syngo CT2012B SOMATOM Definit...
  • Modelo / Serial
    SOMATOM CT System SOMATOM Definition Flash running software version syngo CT2012BSOMATOM Definition Edge running software version syngo CT2012BSOMATOM Definition AS running software version syngo CT2012BSOMATOM Definition running software version syngo CT2012BSOMATOM Definition AS running software version syngo CT2013BARTG numbers: 164065 (SOMATOM system),160853 (syngo software)
  • Manufacturer
    Siemens Ltd

Manufacturer

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