Events

Retiro De Equipo (Recall) de Device Recall Barcode Conical Collimator Verification (BCCV)

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
    60826
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0716-2012
  • Fecha de inicio del evento
    2011-12-12
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106588
  • 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
    When multiple conical collimator treatment plans are scheduled to be treated in a session, the plan label should be displayed on the bccv dialog box should match the plan label on the 4ditc. however, the name of the plan is not being updated correctly.
  • Acción
    The firm, VARIAN Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION-URGENT FIELD SAFETY NOTICE" dated December 12, 2011, to all affected customers. The notice described the product, problem and user corrective action steps. The customers were provided to do the following: Do not use BCCV as a primary reference for identifying the correct plan to be treated; use caution when selecting an isocenter in a positioning system that is not interfaced to the 4DITC; any discrepancies in planned versus actual parameters should be brought to the attention of the medical physicist for investigation before treatment begins, and one workaround is to schedule one plan per session. Special instructions for customers outside the USA and Canada: complete the attached Proof of Notification or Receipt Verification Card once you have read this document and return it to Varian Medical Systems. Varian is developing a technical correction for this issue. The customers will be contacted by a customer representative when this technical correction is available to schedule installation on their system. If you require further clarification, please feel free to call your local Varian Customer Support District or Regional Manager: USA and Canada: 1-888-827-4265; Europe: +41 41 749 8844; Email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support-emea@varian.com; South East Asia: support-sea@varian.com; China/Asia: support-china@varian.com; Japan: support-japan@varian.com and Latin America: soporte.al@varian.com; and Internet: www.myvarian.com or www.varian.com. Additional recall letters were sent on 11/5/12 to additional consignees that Varian determined needed to be notified of the recall.

Device

Device Recall Barcode Conical Collimator Verification (BCCV)
  • Modelo / Serial
    ,HBC0001 , H512022 , H511551 , H511275 ,HBC0004 ,H512993 ,H513292 ,H515900 ,HBC0007 ,H512781 ,H513115 ,H511691 ,HBC0018 ,H512241 ,H515092 ,H513533 ,HBC0021 ,H513561 ,H514438 ,H515524 ,HBC0024 ,H510889 ,H512278 ,H513927 ,HBC0028 ,H515461 ,H515076 ,H514202 ,HBC0048 ,H510126 ,H513080 ,H515780 ,HBC0069 ,H515541 ,H512967 ,H515068 ,HBC0070 ,H511840 ,H513262 ,H510732 ,HBC0075 ,H514160 ,H513701 ,H511593 ,HBC0079 ,H513117 ,H513551 ,H514018 ,HBC0083 ,H511663 ,H511565 ,H512454 ,HBC0090 ,H513989 ,H515570 ,H515064 ,HBC0097 ,H512618 ,H512464 ,H515737 ,HBC0106 ,H514439 ,H515943 ,H515696 ,HBC0111 ,H515691 ,H511821 ,H515523 ,HBC0115 ,H515998 ,H514402 ,H514521 ,HBC0174 ,H515387 ,H514403 ,H513548 ,HBC0210 ,H513769 ,H514080 ,HBC0211 ,H515262 ,H513002 ,HBC0348 ,H514488 ,H512998
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution:USA (nationwide) and countries of: Canada, Australia, Austria, Brazil, China, France, Georgia, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Macau. Malaysia, Mexico, Netherlands, Singapore, Slovenia, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom..
  • Descripción del producto
    Varian brand Barcode Conical Collimator Verification (BCCV) v1.0, Reference/FSCA Identifier: CP-06873, Model Number: HB, distributed by and/or manufactured by: || Varian Medical Systems Inc., Palo Alto, CA || The 4D Integrated Treatment Console [4DITC] is designed to interface to the Varian Clinac Treatment Control System [TCS] for the purpose of providing verification of treatment parameters, imaging and providing a record of treatment. The general function of the 4D Integrated Treatment Console is to allow treatment plans and images to be retrieved from the Oncology Information System [OIS] and sent to the TCS, planned treatment plan parameters to be verified against the TCS delivery parameters for accuracy and treatment history to be recorded in the OIS for use and display. The Barcode Conical Collimator Verification [BCCV] device assists operators of radiation therapy devices by preventing irradiation until the conical collimator required by the treatment plan is in place.
  • 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