Events

Retiro De Equipo (Recall) de VARISEED 8.0

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
    90283
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-07-03
  • 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
    Some variseed users have inadvertently entered a source activity in units of air kerma (u) when the actual source activity was specified in millicuries (mci). variseed requires the user to enter the activity of the source that will be implanted into the patient. the activity may be entered in "u" or "mci". when entering the activity in u the value is accepted and no further message is displayed. if the activity is entered as mci a message is shown indicating that variseed will show "u" in the user interface from that point on and notifying the user of the convered value in u. a data entry error of this nature should be obvious to the user. the variseed software system provides a message at the time data is entered that the user has to click to accept and move forward in planning. also both units of activity are shown on the variseed report headers.

Device

VARISEED 8.0
  • Modelo / Serial
    Model Catalog: 8.0 (Lot serial: Contact manufacturer.); Model Catalog: 8.0 (Lot serial: >10 serial numbers.)
  • Descripción del producto
    Variseed 8.0 (Brachytherapy Treatment Planning System)
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.