Events

Retiro De Equipo (Recall) de Segmented Cylinder Applicator Set

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States 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
    64986
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1324-2013
  • Fecha de inicio del evento
    2013-04-11
  • Fecha de publicación del evento
    2013-05-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117584
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, applicator, radionuclide, remote-controlled - Product Code JAQ
  • Causa
    Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
  • Acción
    Varian Medical Systems, Inc. notified customers of the recall with 'Urgent Medical Device Correction Urgent Field Safety Notice," dated 4/11/13, and delivered by mail to customers. The notice identified the product, problem, and instructions for the customers. Varian Medical Systems, Inc. informed customers of the possible malfunction of the GM11004150 Segmented Cylinder Applicator Set for pulsed dose rate brachytherapy treatment, with codes H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387. The notice instructed customers to cease use of the Segmented Cylinder Applicator Set and return the devices along with a completed proof of notification form (included with the recall notice) to the recalling firm.

Device

Segmented Cylinder Applicator Set
  • Modelo / Serial
    Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and in the countries of: Belgium, France, Martinique, Slovenia, Sweden, and the United Kingdom.
  • Descripción del producto
    Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) || Product Usage: Usage: || Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer.
  • Manufacturer
    Varian Medical Systems, Inc.

Manufacturer

Varian Medical Systems, Inc.
  • Dirección del fabricante
    Varian Medical Systems, Inc., 700 Harris St Ste 109, Charlottesville VA 22903-4584
  • Empresa matriz del fabricante (2017)
    Varian Medical Systems Inc
  • Source
    USFDA