Events

Retiro De Equipo (Recall) de MILLENIUM MLC

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
    35306
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-01-12
  • 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
    When using the hd120 mlc for beam shaping and under specific treatment conditions dose may be delivered outside of the intended treatment field that exceeds the expected transmission dose. this dosimetric property which has been discovered under very specific use conditions with dynamic fields and the hd120 mlc can lead to dose values significantly higher than expected in areas several centimeters away from the edge of the field. the effect is detectable for static mlc cases but only dynamic mlc (imrt) cases were considered to have any potential for significant unexpected dose.

Device

MILLENIUM MLC
  • Modelo / Serial
    Model Catalog: HD120 MLC (Lot serial: HHM0018); Model Catalog: HD120 MLC (Lot serial: H561040); Model Catalog: HD120 MLC (Lot serial: H561141)
  • Descripción del producto
    MILLENIUM MLC
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.