Events

Retiro De Equipo (Recall) de Device Recall Leksell GammaPlan

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
    71295
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1719-2015
  • Fecha de inicio del evento
    2015-06-01
  • Fecha de publicación del evento
    2015-06-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137250
  • 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, radiation therapy, radionuclide - Product Code IWB
  • Causa
    Memory can become corrupted when creating a fused study via drag and drop in leksell gammaplan 10.2.
  • Acción
    The firm, Elekta, sent an "URGENT IMPORTANT FIELD SAFETY NOTICE 100-01-102-015" to all customers on 6/1/2015. The notice described the product, problem and actions to be taken. The customers were instructed to not use drag-and-drop to fuse images as a solution until a permanent fix can be developed and implemented on all affected devices. A solution is in development that will resolve the issue and is expected to be released September 2015. Elekta Service will then work with customers to implement on affected devices - estimated 6 month completion. Customers were also instructed to complete and return the IMPORTANT FIELD SAFETY NOTICE ACKNOWLEDGEMENT form to your local Elekta Office or Representative as soon as possible and within 30 days at the latest. If you have any queries about this Notice, please contact your local Elekta representative or the Global Post market Surveillance Manager at 770-300-9725 or email: Elekta_Global_PMS@elekta.com.

Device

Device Recall Leksell GammaPlan
  • Modelo / Serial
    Software 10.2
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) including states: IL, OH, PA, TX, and WI; and countries of: Germany, Japan and United Kingdom.
  • Descripción del producto
    Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
  • 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