Events

Retiro De Equipo (Recall) de Siemens Digital Linear Accelerators of type Primus, ONCOR and ARTISTE

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
    20516
  • Fecha de inicio del evento
    2016-08-17
  • 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    The manufacturer is informing customers about a new bundled software update that will address multiple issues including issues that have already been previously communicated:, 1. prevention of automatic movements in case of significant risk for collision, 2.Re postioning of 160 mlc after motion stop interlock, 3.Restart of control console, 4. support of tractional monitor units for virtual wedge, 5. transfer of user-defined attributes from one session to another, 6. correction of wrong offset calculation in combination with images acquired with ctvision and also with adaptive targeting option, 7. correction of interrupt of cone beam reconstruction, 8. table rotation values for relative setup, 9. correction of wrong in-session resumption in case of 0 (zero) delivered monitor units, 10. unexpected table movement after internal error message on syngo rt therapist, 11.Update of user documentation "physics primer"., 12.Update of addendum for syngo rt therapist and user documentatio.
  • Acción
    Software to be upgraded

Device

Siemens Digital Linear Accelerators of type Primus, ONCOR and ARTISTE
  • Modelo / Serial
    Model: 8162815 and 8168754, Affected: , Software version: 12.0.25 or 13.0.65 and 4.2.110 or 4.3.SP
  • Manufacturer
    Siemens AG

Manufacturer

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