Events

Retiro De Equipo (Recall) de CLINAC 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
    51828
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-04-20
  • 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
    Collimator cover is falling from the linear accelerator. it appears the collimator cover was not properly installed and that motion of the linear accelerator caused the cover to detach and fall from the machine. it was determined that the collimator latching mechanism may be difficult to latch properly resulting in an increased likelihood of accidental detachment of the collimator cover.

Device

CLINAC LINEAR ACCELERATOR
  • Modelo / Serial
    Model Catalog: 6EX (Lot serial: H180605 (600C Unit)); Model Catalog: 600C (Lot serial: H180600 (600C Unit)); Model Catalog: 6EX (Lot serial: H180796 (6EX Unit)); Model Catalog: 600C (Lot serial: H180796 (6EX Unit)); Model Catalog: 6EX (Lot serial: H180683 (6EX Unit)); Model Catalog: 600C (Lot serial: H180683 (6EX Unit)); Model Catalog: 6EX (Lot serial: H180619 (6EX Unit)); Model Catalog: 600C (Lot serial: H180619 (6EX Unit)); Model Catalog: 6EX (Lot serial: H272910 (6EX unit)); Model Catalog: 600C (Lot serial: H272910 (6EX unit)); Model Catalog: 6EX (Lot serial: H293787 (600C Unit)); Model Catalog: 600C (Lot serial: H293787 (600C Unit)); Model Catalog: 6EX (Lot serial: H291180 (600C Unit)); Model Catalog: 600C (Lot serial: H291180 (600C Unit)); Model Catalog: 6EX (Lot serial: H180600 (600C Unit)); Model Catalog: 600C (Lot serial: H180605 (600C Unit)); Model Catalog: NOVALIS TX (Lot serial: H272857); Model Catalog: 2100C (Lot serial: H272118); Model Catalog: 2100C (Lot serial: H271662); Model Catalog: 2100C (
  • Descripción del producto
    CLINAC LINEAR ACCELERATOR
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.