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
    90596
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-10-28
  • 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
    Rapid arc and vvmat treatment may deliver as dynamic arc on incorrectly configured system. under these circumstances dynamic dose rate and gantry speed features as well as avoidance sectors (range of gantry rotation where no dose should be delivered) that may be part of a vmat plan are not recognized and dose delivered does not match the treatment plan.

Device

NOVALIS TX LINEAR ACCELERATOR
  • Modelo / Serial
    Model Catalog: NOVALIS TX (Lot serial: H294674); Model Catalog: TRILOGY (Lot serial: H140836); Model Catalog: TRILOGY (Lot serial: H291172); Model Catalog: TRILOGY (Lot serial: H294134); Model Catalog: TRILOGY (Lot serial: H294403); Model Catalog: TRILOGY (Lot serial: H294551); Model Catalog: TRILOGY (Lot serial: H294750); Model Catalog: CLINAC IX (Lot serial: Contact manufacturer.); Model Catalog: CLINAC IX (Lot serial: >10 serial numbers.); Model Catalog: 21EX (Lot serial: H272309); Model Catalog: 21EX (Lot serial: H272216); Model Catalog: 21EX (Lot serial: H272158); Model Catalog: 21EX (Lot serial: H272157); Model Catalog: 21EX (Lot serial: H272910); Model Catalog: 21EX (Lot serial: H271926); Model Catalog: 21EX (Lot serial: H271663); Model Catalog: 21EX (Lot serial: H271662); Model Catalog: 21EX (Lot serial: H272310); Model Catalog: 21EX (Lot serial: H271941)
  • Descripción del producto
    Novalis TX Linear Accelerator
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.