Events

Retiro De Equipo (Recall) de Device Recall Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning

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 Integra LifeSciences Corp..

¿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
    63856
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1103-2013
  • Fecha de inicio del evento
    2012-12-10
  • Fecha de publicación del evento
    2013-04-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114917
  • 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
    Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from xknife using dicom-rt.
  • Acción
    Integra initiated a voluntary recall on December 10, 2012 by providing a written Urgent: Medical Device Recall Notification to US consignees who have experienced the software issue due to the configuration of their system. The letter identifies the affected product, as well as, advises customers of the nature of the issue and how it affects treatment records. - Advises customers that they will be contacted when V 5.0.3 software, where the software error has been addressed, is available to schedule an upgrade. - Requests that customer consignees complete and return the Product Recall Acknowledgment Form. If customer have additional questions, they should contact the firm's service hotline at 1-888-772-7378.

Device

Device Recall Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning
  • Modelo / Serial
    Software Versions 5.0.1 and 5.0.2.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
  • Descripción del producto
    Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, || Software Versions 5.0.1 and 5.0.2. || Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.