Events

Retiro De Equipo (Recall) de SYNGO.VIA

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE LIMITED.

¿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
    78053
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-09-19
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Siemens is providing an update package for all systems running on syngo.Via software version va20. this resolves issues encountered with the following software applications: syngo.Via ct - in workflows that contain the mm reading workflow step especially ct neuro perfusion and ct dynamic angio data may not have been loaded to the mm reading workflow step if the data set was assigned to such a workflow scanner site. - in ct bone reading the edit rib function did not work properly: after scrolling multiple times in an mpr image the marker disappeared and after editing a centerline multiple times the edited rib was not correctly displayed in the unfolded rib view. - in ct coronary analysis heart segmentation in vrt images may have been of poor quality as some parts of the heart were missing. - in ct cardiac function the identification of the annular plane did not work in pediatric studies although the system confirmed a completion of preprocessing preprocessing was not completed. syngo.Via mr - in the neuro perfusion workflow the task "remaining images" was missing. therefore it could happen that some series were not available in the workflow. syngo.Via mi - in mm oncology editing a contour could lead to an erroneous segmentation.

Device

SYNGO.VIA
  • Modelo / Serial
    Model Catalog: 10496180 (Lot serial: LOT/SN: 100778 101414 101963)
  • Descripción del producto
    SYNGO.VIA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC