Events

Retiro De Equipo (Recall) de Device Recall NeuViz Dual series Computed Tomography (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 Neuisys, LLC.

¿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
    49012
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2237-2010
  • Fecha de inicio del evento
    2008-07-21
  • Fecha de publicación del evento
    2010-08-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-08-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72515
  • 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
    Computed Tomography X-Ray System - Product Code JAK
  • Causa
    The reference lines for image generated for a surview scan may appear in the incorrect position in the "film" display mode.
  • Acción
    On 07/21/2008, NEUISYS Imaging Systems Solutions distributor in Greensboro, NC began sending the URGENT DEVICE CORRECTION letter on behalf of Philips and NeuSoft Medical Systems (PNMS), Co., Ltd in China. The letter informs the consignees that there is potential safety problem in the NeuViz Dual series CT scanners due to the malfunction of "Incorrect Reference Line in the Film". When a "Head first, Couch out" or a "Feet first, Couch in" Surview scan is started then paused midstream, the image generated is what the doctor expects, but the reference lines appear in the incorrect position in "FILM" display mode. The acquired images accurately represent the exact positions planned on the original view. The incorrect/unmatched reference line in film may result in incorrect diagnosis. The consignees are advised not to stop or pause during Surview acquisition while PNMS in China will provide the updated software patch to all affected systems free of charge. The Field Change Order #FCOP-08-CT-NMS-008 SP4 will be implemented by NEUISYS Imaging Systems Solutions in Greensboro, NC., who is a distributor for PNMS. Consignees are advised to e-mail Service Support Department of PNMS at helpdesk@pnms.neusoft.com regarding the recall.

Device

Device Recall NeuViz Dual series Computed Tomography (CT) Scanner System
  • Modelo / Serial
    Serial Number:  400562, 400563, 400626, NDH009EI, NDH011El, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR08002, and NDHRO80003.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. || Intended to produce cross-section images of head and body by || computer reconstruction of X-ray transmission data taken at different || angles.
  • Manufacturer
    Neuisys, LLC

Manufacturer

Neuisys, LLC
  • Dirección del fabricante
    Neuisys, LLC, 1500 Pinecroft Rd Ste 212, Greensboro NC 27407-3808
  • Empresa matriz del fabricante (2017)
    Neuisys Llc
  • Source
    USFDA