Events

Retiro De Equipo (Recall) de Device Recall HiArt System

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 Accuray Incorporated.

¿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
    59427
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3163-2011
  • Fecha de inicio del evento
    2011-07-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102766
  • 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
    Tomotherapy inc. is sending this field safety notice to make you aware of an anomaly which may affect the performance of the tomomobile hi-art system. tomotherapy has discovered that when attempting to open the tomomobile shielding doors, while the door hinges are in the locked position, the hinges may fail allowing the door to disengage from the shielding.
  • Acción
    The firm, TomoTherapy, sent an "Urgent Medical Device Correction" letter dated July 7, 2011 to its consignees/customers. The letter described the Issue, Product Affected, Recommended Action (advised consignees to not attempt to open the shielding doors when the hinges are in the locked position. The Hinges should always be in the unlocked position when opening the doors) and Resolution. A TomoTherapy field service engineer or an authorized service representative will contact the customers when a resolution is available. If you have any questions, please contact the TomoTherapy Technical Solutions Center by email at support@tomotherapy.com or phone at: North America: 1-866-368-4807; Belgium: 0800 38783; France: 0805 631 565; Germany: 0800 000 7541; Italy: 800 986 399; Netherlands: 0800 020 1364; Spain: 800 300049; Switzerland: 0800 001927; United Kingdom: 0808 238 6035; China/CNC (Northern): 10 800 712 1701; China (Southern): 10 800 120 1701; Hong Kong: 800 967912; Japan: 0044 22 132374; Singapore: 800 1204 683; South Korea: 0079 81 4800 7204, all other locations: +1 608 824 2900 or +32 2 400 44 44.

Device

Device Recall HiArt System
  • Modelo / Serial
    Serial Numbers: 110051 110101 110298 110329
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA including states of: AZ, CA and OK; and country of: United Arab Emirates
  • Descripción del producto
    TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717 || The TomoTherapy HI-ART System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
  • Manufacturer
    Accuray Incorporated

Manufacturer

Accuray Incorporated
  • Dirección del fabricante
    Accuray Incorporated, 1240 Deming Way, Madison WI 53717-1954
  • Empresa matriz del fabricante (2017)
    Accuray Inc
  • Source
    USFDA