Events

Retiro De Equipo (Recall) de Elekta ERGO

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 Elekta 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
    78665
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0234-2018
  • Fecha de inicio del evento
    2017-09-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160084
  • 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,planning,radiation therapy treatment - Product Code MUJ
  • Causa
    Incorrect dicom mapping of the exported collimator or couch angles from ergo, which would lead to incorrect rotation of the collimator or couch when using a mlc device for planning.
  • Acción
    Elekta sent an Urgent Important Field Safety Notification letter dated September, 2017. The letter identified affected product, problem and actions to be taken. Customers were instructed that a copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. The customers were asked to complete the verification tests and return the Important Field Safety Notice Acknowledgment form to their local Elekta representative as soon as possible but no later than 30 days from receipt. For questions contact your local Elekta Care Support Center.

Device

Elekta ERGO
  • Modelo / Serial
    Version 1.7.3 and higher
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: VA, CA, TX, MO, NY, WA, NM, MA, FL, CT, OK, SC, MS, NY, GA, NC and the countries of: AUSTRALIA, BANGLADESH, BRAZIL, BULGARIA, CANADA, COLOMBIA, CZECH REPUBLIC, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ITALY, JAPAN, JORDAN, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, PERU, PHILIPPINES, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, TURKEY, VENEZUELA, and VIETNAM
  • Descripción del producto
    Elekta ERGO++ || Product Usage: || ERGO is often used for stereotactic treatments.
  • Manufacturer
    Elekta Inc

Manufacturer

Elekta Inc
  • Dirección del fabricante
    Elekta Inc, 13723 Riverport Dr Ste 100, Maryland Heights MO 63043-4819
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    USFDA