Events

Retiro De Equipo (Recall) de Siemens SimView NT and SimView NT with IDI

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 Siemens Medical Solutions USA, 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
    69601
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0235-2015
  • Fecha de inicio del evento
    2014-10-10
  • Fecha de publicación del evento
    2014-11-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131032
  • 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, simulation, radiation therapy - Product Code KPQ
  • Causa
    Siemens became aware of a very rare occurrence where an intended movement of the simview nt simulation system components could not be stopped with usual hand control commands or by use of the collision detection functionality. it is possible that simulation system components could collide with patient and/or system equipment.
  • Acción
    Customers were initially notified about the issue by letter on January 7, 2014 (this action was reported as Z-0786-2014 which has been terminated). Siemens promised to notify them when a fix became available. Customer letter, dated November 7, 2014, was sent to notify end users that a fix has become available and Siemens would contact them to schedule an appointment for the correction.

Device

Siemens SimView NT and SimView NT with IDI
  • Modelo / Serial
    Model numbers: 5496992, 5497016   with Serial numbers: 6035, 6080, 6029, 6032, 6019, 6001
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of PA, KY, LA, MA, MI, and CA; and countries of: Argentina, Belarus, Bulgaria, Costa Rico, P.R. China, Curacao, Egypt, Repulic Korea, Germany, Greece, Hungary, Italy, Iraq, Jordan, Malaysia, Palestanian Ter, Poland, Thailand, Turkey, and Vietnam.
  • Descripción del producto
    Siemens SimView NT and SimView NT with IDI simulation system components: || Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Dirección del fabricante
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    USFDA