Events

Retiro De Equipo (Recall) de CLINAC IX RADIO THERAPY DELIVERY SYSTEM

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
    132987
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-01-13
  • 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 under certain circumstances of control circuit adjustments and component failure a c-series clinac can beam on with an asymmetric electron beam which is undetected by the interlocks intended to prevent it. the anomaly can occur in the rare event a balance potentiometer in the electron programming pcb fails and the other circuit settings are such that the effect is not detected.

Device

CLINAC IX RADIO THERAPY DELIVERY SYSTEM
  • Modelo / Serial
    Model Catalog: CLINAC IX (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX (Lot serial: >10 serial numbers.); Model Catalog: 23EX (Lot serial: >10 serial numbers.); Model Catalog: 21EX (Lot serial: >10 serial numbers.); Model Catalog: 2100C/D (Lot serial: >10 serial numbers.); Model Catalog: 2300C/D (Lot serial: >10 serial numbers.); Model Catalog: 21EX (Lot serial: Contact manufacturer.); Model Catalog: 23EX (Lot serial: Contact manufacturer.); Model Catalog: 2100C/D (Lot serial: Contact manufacturer.); Model Catalog: 2300C/D (Lot serial: Contact manufacturer.); Model Catalog: TRILOGY (Lot serial: H293883); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H294134); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H291166); Model Catalog: TRILOGY (Lot serial: H293787)
  • Descripción del producto
    Clinac IX Radiotherapy Delivery System
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.