Events

Retiro De Equipo (Recall) de CLINAC IX HIGH ENERGY LINEAR ACCELERATOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada 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
    95992
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-04-23
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Under certain conditions photon beams in high energy clinacs may experience a gradual change in beam symmetry potentially reaching an asymmetry of up to approximately 7 % before interlock occurs. at maximum asymmetry this may result in no more than approximately 3.5% dose deviation from expected at any point in the beam. the type of asymmetry normally results in a beam which is higher than desired on one side of the central axis lower on the other side and approximately correct at the central axis. asymmetry value as used here means the peak to peak (over to under) differences observed. therefore a maximum asymmetry of 7% will result in a dose deviation of no more than 3.5% at any point in the beam with a smaller deviation near the central axis of the beam. normally the central axis dose values represent the calibration point and are not affected.

Device

CLINAC IX HIGH ENERGY LINEAR ACCELERATOR
  • Modelo / Serial
    Model Catalog: CLINAC IX (Lot serial: >10 serial numbers.); Model Catalog: CLINAC IX (Lot serial: contact manufacturer.); Model Catalog: 21EX (Lot serial: contact manufacturer.); Model Catalog: 21EX (Lot serial: >10 serial numbers.); Model Catalog: TRILOGY (Lot serial: H294991); Model Catalog: 2100C (Lot serial: H272118); Model Catalog: TRILOGY (Lot serial: H294551); Model Catalog: TRILOGY (Lot serial: H293787); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H294934); Model Catalog: TRILOGY (Lot serial: H294750); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: 2100C (Lot serial: H270838); Model Catalog: 2100C (Lot serial: H270544); Model Catalog: 2100C (Lot serial: H270823); Model Catalog: 2100C (Lot serial: H271161); Model Catalog: 2100C (Lot serial: H270708); Model Catalog: TRILOGY (Lot serial: H291166)
  • Descripción del producto
    Clinac IX High Energy Linear Accelerator
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.