Events

Retiro De Equipo (Recall) de Device Recall NeuViz 64 Multislice CT Scanner 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 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
    77608
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3044-2017
  • Fecha de inicio del evento
    2017-05-19
  • 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=156762
  • 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
    Software defect.
  • Acción
    Neusoft Medical Systems will bring defect into compliance: The defect will be remedied by updating software. Field Change Order I related to software updated will be released to the affected systems in ' Aug, 2017. The affected systems will be upgraded with updated software in the field free of char e in 6 months after the FCO release.

Device

Device Recall NeuViz 64 Multislice CT Scanner System
  • Modelo / Serial
    NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide distribution
  • Descripción del producto
    Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: || NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, || NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version || Product Usage: || The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
  • 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