Events

Retiro De Equipo (Recall) de Device Recall NeuViz 64

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 Neusoft Medical Systems Co., Ltd..

¿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
    75383
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0875-2017
  • Fecha de inicio del evento
    2016-08-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-01-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150174
  • 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, x-ray, tomography, computed - Product Code JAK
  • Causa
    The firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. the system must be powered down and restarted to clear the interruption error before scanning can resume.
  • Acción
    Neusoft Medical Systems Co. Ltd. planned action to bring into compliance. 1.Affected Customers will be notified by letter to provide them a description of the affected device, instructions for using the device prior to correction, hazards associated with the defect, and a statement of corrective actions to be taken at no cost to the owner. 2.Field Service Engineers will visit owner sites to install a software update which resolves the defect. 3.Corrections will be made at no cost to the owner 4.Corrections will be completed by May 11, 2017. CDRH approves the CAP subject to the following conditions: .Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. Further questions please call (281) 453-1205.

Device

Device Recall NeuViz 64
  • Modelo / Serial
    NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P04 or previous version.  NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P05 or previous version
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution
  • Descripción del producto
    NeuViz 64 Multi-slice CT Scanner Systems
  • Manufacturer
    Neusoft Medical Systems Co., Ltd.

Manufacturer

Neusoft Medical Systems Co., Ltd.
  • Dirección del fabricante
    Neusoft Medical Systems Co., Ltd., NO. 16 Shiji Road, Hunnan Industrial Area, Shenyang China
  • Source
    USFDA