Events

Retiro De Equipo (Recall) de Device Recall VARIAN HIGH ENERGY LINEAR ACCELERATOR

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. Oncology Systems.

¿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
    58438
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2195-2011
  • Fecha de inicio del evento
    2011-03-28
  • Fecha de publicación del evento
    2011-05-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99348
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    Varian has identified an anomaly whereby, following prolonged use, the screw fastener holding the wedge body to the tray may fail.
  • Acción
    The firm, Varian Medical, sent an "Urgent Medical Device Correction" Letter dated March 28, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately inspect all hard wedges for missing or sheared screw fasteners, if any wedge is found to have one or more missing or sheared screw fasteners, remove the wedge from use and notify Varian immediately; inspect all hard wedges for loose screw fasteners, and retighten as necessary, and implement a program of monthly inspection of wedges for loose or missing hardware. The customers were also instructed to advise the appropriate personnel working in their Radiotherapy Department of the content of this letter. Varian Service shall immediately begin an interim action to replace screw fasteners on all hard wedges for Clinacs installed prior to January 2004. Varian Service will contact the customers to arrange for the inspection visit. Varian also stated that they shall continue their Investigation of this issue to further clarify the exact conditions under which the wedge screw fasteners may fail, and to analyze possible final solutions. Varian will notify the customers when final determinations are made. If you require further clarification, please feel free to contact your local Varian Customer Support Services Manager and/or USA and Canada at 1-888-4265; Europe: +41 41 749 8844; or email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support emea@varian.com; South East Asia: seasia.apps.helpdesk@varian.com; China/Asia: china.apps.Helpdesk@varian.com; Japan: Japan.apps helpdesk@varian.com; Latin America: soporte.al@varian.com, a d Internet: Oncology Systems-www.myvarian.com or Varian Medical Systems - www.varian.com.

Device

Device Recall VARIAN HIGH ENERGY LINEAR ACCELERATOR
  • Modelo / Serial
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution:
  • Descripción del producto
    Varian brand Clinac, Medical Linear Accelerator, All Varian Clinac with Model Numbers: H14, H18, H26, H27, H28, H29, Hcx; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Dirección del fabricante
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Empresa matriz del fabricante (2017)
    Varian Medical Systems Inc
  • Source
    USFDA