Events

Retiro De Equipo (Recall) de NOVALIS TX LINEAR ACCELERATOR

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
    130306
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-06-29
  • 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
    An anomaly has been identified whereby following prolonged use the screw fastener holding the wedge body to the tray may fail. the falling wedge presents a risk of injury to patients or other personnel in the path of the falling wedge. the risk of failure is proportional to the amount of use of the wedge and is considered significant only after many years of use. the risk is also increased for heavier wedges upper wedges used in the interface mount and for wedges where the screw fasteners are loose or have a history of becoming loose. varian is aware of this occuring only for 30 degree upper wedges. other wedges may potentially be susceptible to the same failure.

Device

NOVALIS TX LINEAR ACCELERATOR
  • Modelo / Serial
    Model Catalog: NOVALIS TX (Lot serial: H294674); Model Catalog: TRILOGY (Lot serial: H294750); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: TRILOGY (Lot serial: H294934); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H293883); Model Catalog: TRILOGY (Lot serial: H294134); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H294551); Model Catalog: TRILOGY (Lot serial: H293787); Model Catalog: TRILOGY (Lot serial: H291166); Model Catalog: (Lot serial: Contact Manufacturer.); Model Catalog: (Lot serial: >10 Serial Numbers.); Model Catalog: CLINAC IX (Lot serial: >10 Serial Numbers.); Model Catalog: CLINAC IX (Lot serial: Contact Manufacturer.)
  • Descripción del producto
    NOVALIS TX LINEAR ACCELERATOR
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.