Events

Retiro De Equipo (Recall) de Siemens 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
    20858
  • Fecha de inicio del evento
    2016-11-23
  • 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
    For artis systems with software version vc21c, vd11, and megalix cat+ x-ray tubes, the semi-automatic focus switch may in cases of a special type of defect in foci small and micro (if present), not work as intended when pressing the footswitch multiple times. this special type of focus defect, that causes the failure of the semi-automated focus switch, becomes more likely as the service life of the x-ray tube increases.
  • Acción
    Software to be upgraded

Device

Siemens Artis Q, Q.zen, zeego, zee systems
  • Modelo / Serial
    Model: , Affected: Artis zee with SW versions VC21C, VD11 and Megalix Cat+ X-ray tubes - Lot numbers 10280959, 10094139, 10094141, 10094135, 10094137
  • Manufacturer
    Siemens Healthcare GmbH

Manufacturer

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