Events

Retiro De Equipo (Recall) de Siemens Artiste syngo RT Therapist (RTT) Software

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 AG.

¿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
    16028
  • Fecha de inicio del evento
    2014-01-13
  • 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
    There is a potential safety issue when using the "in-session resumption" feature of the syngo rt therapist 4.3 software. this feature allows for one or more partially delivered beams to be re-delivered to make up for the deficit in total monitor units (mu) planned for delivery., in a rare scenario in which several conditions are fulfilled, the system will send the already treated beam again to the control console of the linear accelerator for full delivery. this will result in a greater dose being delivered than was planned.
  • Acción
    Software to be upgraded

Device

Siemens Artiste syngo RT Therapist (RTT) Software
  • Modelo / Serial
    Model: , Affected: , Software version: Version 4.3
  • Manufacturer
    Siemens AG

Manufacturer

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