Events

Retiro De Equipo (Recall) de Siemens syngo CT Software

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Siemens AG.

¿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
    15857
  • Fecha de inicio del evento
    2013-12-11
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    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 recognize the malfunction and continue the interventional procedure.
  • Acción
    Software to be upgraded

Device

Siemens syngo CT Software
  • Modelo / Serial
    Model: , Affected: , Software version: Syngo version CT2012B and CT2013B
  • Manufacturer
    Siemens AG

Manufacturer

Siemens AG
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA