Events

Retiro De Equipo (Recall) de Monaco Image Statistics Tool

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 Elekta Inc.

¿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
    17909
  • Fecha de inicio del evento
    2014-12-22
  • 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: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • Causa
    When a ct phantom is scanned and the images are transferred to monaco, it is possible to sample the densities using the image statistics tool in monaco. in the case where ct slice thickness is not the same as ct slice spacing the image statistics tool will report an incorrect hu. if the user bases their ct to ed file on this incorrect density information, dose calculation errors will result. the magnitude of the dose calculation error will be dependent on the magnitude of the hu error.
  • Acción
    Software to be upgraded

Device

Monaco Image Statistics Tool
  • Modelo / Serial
    Model: Monaco, Affected: Rel 3.30 and higher
  • Manufacturer
    Elekta Inc

Manufacturer

Elekta Inc
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    NZMMDSA