Events

Retiro De Equipo (Recall) de ECLIPSE TPS V8.8

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
    70181
  • 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
    Software anomaly seen with eclipse electron monte carlo (emc) algorithm where no-equidistant data points in the open beam profile used during configuration may lead to inaccurate results. in a customer report seen (where no patients were involved) beam data collection with non-equidistant data points can lead to inaccurate dose distributions in the treatment plan. the sample dataset from the customer showed a 30% dose difference between the treatment plan isodose plot and the actual delivered dose.

Device

ECLIPSE TPS V8.8
  • Modelo / Serial
    Model Catalog: 100042024 (Lot serial: >10 Serial Numbers.); Model Catalog: TPA001075000 (Lot serial: >10 Serial Numbers.); Model Catalog: TPA001075000 (Lot serial: Contact manufacturer.); Model Catalog: 100042024 (Lot serial: Contact manufacturer.); Model Catalog: TPA001094000 (Lot serial: H484530); Model Catalog: TPA001094000 (Lot serial: H484531); Model Catalog: TPA001094000 (Lot serial: H484526); Model Catalog: TPA001094000 (Lot serial: H484527); Model Catalog: TPA001094000 (Lot serial: H484528); Model Catalog: TPA001094000 (Lot serial: H487506); Model Catalog: UP9001 (Lot serial: >10 Serial Numbers.); Model Catalog: UP9001 (Lot serial: Contact manufacturer.)
  • Descripción del producto
    ECLIPSE TPS V8.8
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.