Events

Retiro De Equipo (Recall) de Varian Eclipse Treatment Planning Program

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 Varian Medical Systems 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
    19673
  • Fecha de inicio del evento
    2016-01-19
  • 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: Varian Medical Systems Australasia Pty Ltd (NZ), C/- BDO Auckland - Christine Koefoed, Level 4, BDO Centre, 4 Graham Street, Auckland 1140
  • Causa
    Manufacturer has received a report of an anomaly involving eclipse™ treatment planning system pencil beam convolution (pbc) 11.0.31 to compute a conventional arc dose distribution. when using pbc 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments with eclipse versions 11, 13, 13.5 or 13.6, the displayed dose does not correspond to the calculated monitor units (mu). varian has not received any report of misadministration due to this issue.
  • Acción
    Software to be upgraded

Device

Varian Eclipse Treatment Planning Program

Manufacturer

Varian Medical Systems Inc