Events

Retiro De Equipo (Recall) de Device Recall TomoTherapy 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 TomoTherapy 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
    56166
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2219-2010
  • Fecha de inicio del evento
    2009-12-01
  • Fecha de publicación del evento
    2010-08-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92786
  • 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
    An issue was identified with the tomotherapy hi-art system. in the event a patient or dqa plan has a moved image, roll adjustments applied during registration will be incorrect. the planning station plan settings and dqa setup tabs allow for images to be moved during planning. during registration when roll is applied on moved images, the operator station incorrectly rolls the image about.
  • Acción
    Consignee was sent a TomoTherapy "Urgent Medical device Correction Field Safety Notice' dated December 01, 2009. The letter described the Issue, Product Affected, Recommended Action and Resolution.

Device

Device Recall TomoTherapy HIART System
  • Modelo / Serial
    110019
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    VA
  • Descripción del producto
    Hi-Art System, H-0000-0003 || Usage: 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
    TomoTherapy Incorporated

Manufacturer

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