Retiro De Equipo (Recall) de SOMATOM CTs: Definition Flash, Definition Edge, Definition AS and Definition (full body CT diagnostic x-ray systems) equipped with software syngo CT2010A, CT2010B, CT2011A and CT2012B

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-2012-RN-01298-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-01-08
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    There is a sporadic malfunction concerning 3d reconstructions during activated "preview image" functionality. the problem may occur during the process of 3d recon job planning and editing within the "examination" card while the "preview image" functionality is activated; when switching then to another recon job the system might sporadically hang up.
  • Acción
    The customer letter identifies the software workarounds to mitigate the problems temporarily. Siemens will schedule software upgrades shortly for mitigating the problems permanently.

Device

  • Modelo / Serial
    SOMATOM CTs: Definition Flash, Definition Edge, Definition AS and Definition (full body CT diagnostic x-ray systems) equipped with software syngo CT2010A, CT2010B, CT2011A and CT2012BARTG Number: 164065
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA