Events

Retiro De Equipo (Recall) de Device Recall TomoTherapy HiArt System, Version 4.0.0 & 4.0.1.

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
    56052
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2115-2010
  • Fecha de inicio del evento
    2010-02-22
  • Fecha de publicación del evento
    2010-08-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92546
  • 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
    Radiation Therapy System - Product Code MUJ
  • Causa
    In some cases, the patient's diagnostic ct image is narrower than the hi-art radiotherapy couch image.
  • Acción
    Consignees were sent on 2/22/10 a TomoTherapy Incorporated "Urgent Medical Device Correction Field Safety Notice" letter dated Monday, February 22, 2010. The letter was addressed to TomoTherapy Customer and identified the the affected product, and included a description of the Issue, Product Affected, Recommendation Actions and Resolution. The issue will be remedied by software versions 4.0.2 and later. Questions should be directed towards TomoTherapy Customer Interaction Center by e-mail or telephone.

Device

Device Recall TomoTherapy HiArt System, Version 4.0.0 & 4.0.1.
  • Modelo / Serial
    Serial #'s: 110019. 110037, 110056, 110091, 110169, 110281.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA.
  • Descripción del producto
    TomoTherapy Hi-Art System¿, Version 4.0.0 & 4.0.1. || TomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. || Intended to be used as an integrated system for 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.
  • 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