Events

Retiro De Equipo (Recall) de ECLIPSE

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
    101652
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-06-03
  • 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
    An anomaly was discovered in which a second or subsequent user can access a patient record which is already open at another workstation and if they ignore the warning the message that the record is being edited by another user and proceed to edit the plan and save the record a corrupted but usable patient plan record may result. errors can include but are not limited to incorrect mu incorrect beam modifiers incorrect gantry angles incorrect field sizes etc.

Device

ECLIPSE
  • Modelo / Serial
    Model Catalog: V.6.5 (Lot serial: manufacturer.); Model Catalog: V.6.5 (Lot serial: >10 units. Contact); Model Catalog: VERSION 6.5 (Lot serial: >10 units. Contact); Model Catalog: VERSION 6.5 (Lot serial: manufacturer.)
  • Descripción del producto
    Eclipse
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.