Events

Retiro De Equipo (Recall) de Varian C-Series High Energy Linear Accelerator

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
    16913
  • Fecha de inicio del evento
    2014-07-04
  • 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
    Varian has received several reports of unexpected beam output variations with the c-series high energy [he] linear accelerator for 6mv photon treatment mode. the issue has been reported for versions 7, 8 and 9 with 6 mv configuration and maximum dose rate of at least 600 mu/min only. it was determined during intensive investigation that the 6mv target had developed a cavity or hole. degradation of the target led to beam output and symmetry changes which were not detected by the linear accelerator. the result is that a lower than intended dose could be delivered to the target volume if treatment were to take place. varian has not received any report of misadministration or injury due to this 6mv target degradation or failure.
  • Acción
    Software to be upgraded

Device

Varian C-Series High Energy Linear Accelerator
  • Modelo / Serial
    Model: Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300 C/D, Clinac DHX, Clinac 21EX, Clinac 23EX, Affected: , Software version: Version: 7, 8 and 9 with 6 MV configuration and maximum dose rate of at least 600 MU/min ONLY
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc