Events

Retiro De Equipo (Recall) de Device Recall NeuViz 16 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 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
    64783
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1165-2013
  • Fecha de inicio del evento
    2013-03-04
  • Fecha de publicación del evento
    2013-04-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117085
  • 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
    User error of the neuviz 16 or neuviz dual may cause personnel injuries. there was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel.
  • Acción
    The firm, Neusoft Medical Systems Co., Ltd., sent an "URGENT DEVICE CORRECTION" NeuViz Dual and NeuViz 16 letter, dated Mar. 4, 2013, to their US consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to review this information with all members of their staff and retain a copy of the letter with the equipment Instruction For Use. Customers with questions should contact the Service Support Department by email to nms-service@neusoft.com

Device

Device Recall NeuViz 16 MultiSlice CT Scanner System
  • Modelo / Serial
    Serial numbers: N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120020, N16E120022, N16E120023, N16E120024, N16E120052, N16E120053, and N16E130002.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.
  • Descripción del producto
    NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. || The NeuViz 16 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 with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients
  • 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., 16 Century Road, Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning China
  • Source
    USFDA