Events

Retiro De Equipo (Recall) de Device Recall NeuViz Dual Series Computed Tomography 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 Philips And 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
    54638
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0846-2011
  • Fecha de inicio del evento
    2010-02-10
  • Fecha de publicación del evento
    2011-01-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88867
  • 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
    NeuViz Dual Series Computed Tomography Scanner System - Product Code JAK
  • Causa
    Potential for the ct patient table top to become detached from the carrier due to missing washers.
  • Acción
    Neusoft Medical Systems Co., China sent an URGENT DEVICE CORRECTION letter dated Feb. 10, 2010 to their distributor in NC. On 02/12/10, The distributor sent the same letter to their consignees. The firm informed this distributor that there was report of the four screws that secure the patient table top to the carrier that did not have the proper washers in place which caused the table top to detach. If the issue would reoccur, there is a potential for the table top to fall and cause patient injury. Customers were instructed to check the patient table top fixing. If it is found that the the assembly is improper customers were instructed to top using the product and contact local Service personnel for repair. Any customer can contact Service Support Department, Neusoft Medical Systems Co, LTD at nms-service@neusoft.com or Service Support Department at helpdesk@neusoft.com for questions about this recall.

Device

Device Recall NeuViz Dual Series Computed Tomography Scanner System
  • Modelo / Serial
    Part number: NeuViz Dual 989605651321.  SERIAL NUMBERS:  400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR080031, NDHR090003, and NDHR090012.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including NC
  • Descripción del producto
    The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. || Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***". || Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles.
  • Manufacturer
    Philips And Neusoft Medical Systems Co., Ltd.

Manufacturer

Philips And Neusoft Medical Systems Co., Ltd.
  • Dirección del fabricante
    Philips And Neusoft Medical Systems Co., Ltd., Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning China
  • Source
    USFDA