Events

Retiro De Equipo (Recall) de Device Recall CT Scanner

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
    73832
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1650-2016
  • Fecha de inicio del evento
    2015-05-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145070
  • 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
    It was found by r&d; in april, 2014 that there was a defect in neuviz 64 system software version 1.0.5+p09. the icons of side decubitus didn't meet the patient position description, when the scanner position was set to "right" in the system setting - scanner options.
  • Acción
    An upgraded software version (1.0.5.2619+P11) was released on May 7, 2015. The FCO was released to the service engineers of Neusoft Medical Systems USA, which is subsidiary of the reporting firm, and the engineers performed FCO for each affected device together with the distributors' engineers. The corrections (FCOs to upgrade software) on all the affected systems in the USA have been completed. At present (4/27/16) there is no longer this issue on the systems, so no further actions are needed for customers/distributors. However, the recalling firm shall inform the direct accounts of this fix before May 5, 2016. The recalling firm will submit the communication evidence ASAP once they have evidence of the communication. For further questions, please call (281) 453-1205.

Device

Device Recall CT Scanner
  • Modelo / Serial
    Serial Numbers: N64E120022E, N64E130039E, N64I130051E, N64E130062E, N64E130063E, N64E130066E, N64I140077E
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution - Including Puerto Rico and the states of IL, CT, SC, NE
  • Descripción del producto
    NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
  • 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