Events

Retiro De Equipo (Recall) de SEGMENTED CYLINDER SET

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
    127918
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-08-04
  • 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
    In the previous recall (55250) the blocking washer on the flexible probe (gm11002420) may shift and users are not to use a flexible probe with an unstable or shifted blocking washer due to potential for treatment error. this update notice supplements and modifies the previous instructions that you may continue to use the original design flexible probe with blocking washer and old design guiding tube. here users are instructed to stop using these older products (gm11002420 flexible applicabtor probe with blocking washer at 234 mm (old design) gm11005170 guiding tube for segmented cylinders (old design). this update notice request requires that users return these original design products to varian brachytherapy for replacement with the updated designs for them free of charge.

Device

SEGMENTED CYLINDER SET
  • Modelo / Serial
    Model Catalog: GM11004150 (Lot serial: >10 Serial numbers.); Model Catalog: GM11004150 (Lot serial: Contact manufacturer.)
  • Descripción del producto
    SEGMENTED CYLINDER SET
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.