Retiro De Equipo (Recall) de ARTIS zee/Q systems with Large Display

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 Healthcare Pty 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-2018-RN-00449-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-08
  • 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
    It has been identified by siemens 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
    Siemens is advising they will contact impacted customers to arrange a firmware update to correct this issue.

Device

  • Modelo / Serial
    ARTIS zee/Q systems with Large DisplayCatalogue Numbers: 10094137, 10094135, 10280959, 10848281, 10848283, 10094141WAND Number: 160415-WAND-6LT3VYARTG Number: 273952Siemens Healthcare - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DHTGA