Events

Retiro De Equipo (Recall) de Device Recall Regulation Number 892.5700

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
    61179
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1199-2012
  • Fecha de inicio del evento
    2012-01-05
  • Fecha de publicación del evento
    2012-03-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107467
  • 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
    Components of medical device used in brachytherapy may be defective and cause a shifted dose distribution to patients.
  • Acción
    Varian Medical Systems sent an Urgent Medical Device Correction - Urgent Field Safety Notice letter dated January 5, 2012 to all affected consignees. The letter identified the affected products, description of problem and recommended user actions to be taken. Consignees were requested to cease use of the affected products and contact Varian BrachyTherapy Helpdesk immediately to arrange return of their affected parts. Consignees were requested to return the enclosed proof of notification form. Consignees were instructed to advise the appropriate personnel working in their radiotherapy department of the content of this letter. For future reference, this document will be posted to the Varian Customer Support website: http://www.MyVarian.com. For further clarification contact your local Varian District or Regional Manager.

Device

Device Recall Regulation Number 892.5700
  • Modelo / Serial
    All lots of the components are recalled. Components are used as adapters for the Varian Afterloaders with the following serial numbers:  H600097 H600254 H600255 H600268 H600274 H600341 H600345 H600352 H600377 H600381 H600416 H600435 H600437 H600462 H600513 H600524 H600538 H600546 H600548 H600583
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Including the states of CA, FL, IN, KY, MI, MN, MO, OH, TX, VA and the countries of Canada, Japan and Sweden.
  • Descripción del producto
    Nucletron Adapter and Transfer Guide Tube Set, part number AL 13005001, set of 3 adapters, components used with the VariSource" IX HDR Afterloader. || Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient.
  • 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