Events

Retiro De Equipo (Recall) de Elekta X-Ray Volume Imaging System (XVI)

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 Limited (England).

¿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
    15809
  • Fecha de inicio del evento
    2014-10-17
  • 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
    The xray volume imaging system (xvi) can incorrectly calculate the target position of the treatment table, because of an error due to a specific sequence of events that does not occur very frequently., if patient and treatment table movements are not monitored ,and the automatic setup buttons are kept pressed ,the treatment table continues to move. it only stops when a touchguard activates. therefore this error can cause a collision between the patient and an external beam limiting device. if this error occurs with an external beam limiting device attached to the digital accelerator, it may cause fatal injury to the patient.
  • Acción
    Software to be upgraded

Device

Elekta X-Ray Volume Imaging System (XVI)
  • Modelo / Serial
    Model: , Affected: , Software version: R4.5, R4.5.1, R4.6 to R5.0
  • Manufacturer
    Elekta Limited (England)

Manufacturer

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