Events

Retiro De Equipo (Recall) de Device Recall iGUIDE 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 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
    74087
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1705-2016
  • Fecha de inicio del evento
    2016-05-12
  • Fecha de publicación del evento
    2016-05-23
  • 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=146250
  • 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
    Accelerator, linear, medical - Product Code IYE
  • Causa
    If by mistake the initial pre-treatment imaging was performed before the hexapod was moved to the drive (*start) position, iguide offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.
  • Acción
    Elekta sent an Important Field Safety Notice that was distributed to all affected customers on May 12, 2016. The notice informs end users about the problem and the potential clinical impact. It also gives a recommendation how the risk can be mitigated. The notice also advises the customer that a patch will be released that will introduce a patch that avoids an inaccurate position and thus eliminates an unsafe situation. Corrective Action #2: Permanent Solution  Software Upgrade A software patch will be released that will correct the behavior of the iGUIDE software. The target release date for this patch is January 2017. Service teams will have 6 months from the date of release to correct all affected devices in the field. For further questions, call (770) 300-9725.

Device

Device Recall iGUIDE System
  • Modelo / Serial
    Software iGUIDE 2.1 and 2.2
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan
  • Descripción del producto
    iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
  • Manufacturer
    Elekta, Inc.

Manufacturer

Elekta, Inc.
  • Dirección del fabricante
    Elekta, Inc., 400 Perimeter Center Ter NE Ste 50, Atlanta GA 30346-1227
  • Empresa matriz del fabricante (2017)
    Elekta AB
  • Source
    USFDA