Events

Retiro De Equipo (Recall) de ECLIPSE SMART SEGMENTATION

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
    31043
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-07-19
  • 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
    An anomaly has been identified with certain aaa versions where the second source modeling for imrt fields with multiple carriage groups is incorrect. in affected aaa versions when modeling the second source the collimator jaw positions are read from the first control point of the field. this can cause an underestimation of the dose when calculating an imrt field which has multiple carriage groups. when the plan is delivered the delivered dose can be higher than planned locally by up to 10%.

Device

ECLIPSE SMART SEGMENTATION
  • Modelo / Serial
    Model Catalog: TPA001094000 (Lot serial: Contact manufacturer.); Model Catalog: TPA001094000 (Lot serial: >10 Serial numbers.); Model Catalog: UP9001 (Lot serial: >10 serial numbers.); Model Catalog: UP9001 (Lot serial: Contact manufacturer.); Model Catalog: TPA001075000 (Lot serial: >10 Serial numbers.); Model Catalog: TPA001075000 (Lot serial: Contact manufacturer.); Model Catalog: 100042024 (Lot serial: H48C062); Model Catalog: 100042024 (Lot serial: H48C063); Model Catalog: 100042024 (Lot serial: H48A242); Model Catalog: 100042024 (Lot serial: H48A478)
  • Descripción del producto
    ECLIPSE SMART SEGMENTATION
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.