Events

Retiro De Equipo (Recall) de MULTILEAF COLLIMATOR

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
    47235
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-16
  • 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
    Failure to retract or park the varian mlc leaves prior to use of the demountable brainlab m3 could result in the varian mlc leaves interfering with treatment field defined by brainlab m3 without an interlock being asserted. when a demountable brainlab m3 mlc is installed on a varian accelerator the use of two a-b switches is required to deploy the desired mlc. both switches must be set to the correct position prior to use. the first a-b switch box connects the mlc workstation to either the varian mlc controller or to the brainlab m3 controller. the second a-b switch box connects the clinac console to either the varian mlc controller or the brainlab m3 controller. this connection includes the mlc interlock used to inhibit radiation from the clinac accelerator. the mlc that is not selected on this a-b switch is disconnected from the interlock circuitry.

Device

MULTILEAF COLLIMATOR
  • Modelo / Serial
    Model Catalog: MLC 52 (Lot serial: H520320); Model Catalog: MILLENIUM 80 (Lot serial: H542533); Model Catalog: MLC 52 (Lot serial: H542533); Model Catalog: MILLENIUM 80 (Lot serial: H520320); Model Catalog: MILLENIUM 80 (Lot serial: H542182); Model Catalog: MLC 52 (Lot serial: H542182)
  • Descripción del producto
    MULTILEAF COLLIMATOR
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.