Retiro De Equipo (Recall) de Artis Q, Q.zen, zeego, zee systems

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 Healthcare GmbH.

¿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
    22949
  • Fecha de inicio del evento
    2018-05-08
  • País del evento
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
  • 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
    The manufacturer has indentified that the large display does not show an image due to a technical problem. this might occur after the large display returns from power save mode. the large display stays black without showing an error message. x-ray is still possible. the problem occurs sporadically and only when the display is returning from power save mode. it does not occur during an ongoing procedure.
  • Acción
    Software to be upgraded

Device

  • Modelo / Serial
    Model: Catalogue number – 10094137, 10094135, 10280959, 10848281, 10848283, 10094141, Affected:
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    NZMMDSA