Events

Retiro De Equipo (Recall) de VAGINAL-APPLICATOR 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
    18354
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-07-29
  • 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 previous recall (hc# 55250) this addressed the flexible applicator probes that can shrink by up to 2mm after autoclaving. it has been determined that a portion of the shipped inventory of flexible applicator probes was not heat annealed. this recall supplements previous instructions by requring users to stop using any flexible applicator probes that may still be in inventory with lot numbers d01 to h14 inclusive. these applicator probes are to be returned to varian brachytherapy for replacement with lots after h14.

Device

VAGINAL-APPLICATOR SET
  • Modelo / Serial
    Model Catalog: GM11002560 (Lot serial: Contact manufacturer.); Model Catalog: GM11002560 (Lot serial: >10 lot numbers.); Model Catalog: GM11002560 (Lot serial: )
  • Descripción del producto
    VAGINAL-APPLICATOR SET
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.