Events

Retiro De Equipo (Recall) de VARIS - 4D INTEGRATED TREATMENT CONSOLE (4DITC)

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
    130916
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-11-17
  • 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
    Malfunction when adding cbct image. present software has ability to acquire gantry angle when 'treatment approval enforced' and/or 'allow only couch parameter (vert long lat) editing & acquiring for approved plans' selected in treatment administration. therapists can acquire gantry angle into plan even without system rights to acquire gantry angle. patient treated with wrong gantry angles one day.

Device

VARIS - 4D INTEGRATED TREATMENT CONSOLE (4DITC)
  • Modelo / Serial
    Model Catalog: 8.0.23 SP2 (Lot serial: manufacturer.); Model Catalog: 8.0.12 (Lot serial: >10 serial numbers. Contact); Model Catalog: 8.0.23 SP2 (Lot serial: >10 serial numbers. Contact); Model Catalog: 8.1 SP2 (Lot serial: >10 serial numbers. Contact); Model Catalog: 8.1.1.3 (Lot serial: >10 serial numbers. Contact); Model Catalog: H51 (Lot serial: manufacturer.); Model Catalog: 8.8.0 (Lot serial: manufacturer.); Model Catalog: 8.6.2 (Lot serial: manufacturer.); Model Catalog: 8.6.1 (Lot serial: manufacturer.); Model Catalog: 8.6 (Lot serial: manufacturer.); Model Catalog: 8.3 (Lot serial: manufacturer.); Model Catalog: 8.1.4 (Lot serial: manufacturer.); Model Catalog: 8.1.3 (Lot serial: manufacturer.); Model Catalog: 8.1.2 (Lot serial: manufacturer.); Model Catalog: 8.1.1.4 (Lot serial: manufacturer.); Model Catalog: 8.1.1.3 (Lot serial: manufacturer.); Model Catalog: 8.1 SP2 (Lot serial: manufacturer.); Model Catalog: 8.0.12 (Lot serial: manufacturer.); Model Catalog: H51 (Lot serial: >10 serial numbers.
  • Descripción del producto
    Varis 4D Integrated Treatment Console
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.