Events

Retiro De Equipo (Recall) de NeuViz 16 MultiSliced CT Scanner System and NeuViz Dual series 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
    63553
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0466-2013
  • Fecha de inicio del evento
    2012-10-18
  • Fecha de publicación del evento
    2012-12-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-07-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114197
  • 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
    The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. this issue may affect neuviz dual and neuviz 16 scanners.
  • Acción
    Philips and Neusoft Medical Systems Co., Ltd. sent an Urgent Device Correction NeuViz Dual, NeuViz 16 letter, dated Oct. 18, 2012, to all affected US customers and distributors. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to: 1. Have a mechanic check the patient table top screws fixing. Detailed instructions are attached as Annex with the letter. 2. If it is found that table top screws are improperly assembled, stop using the product and contact local Service personnel for repair. Philips and Neusoft Medical Systems Co., Ltd is in the process of upgrading devices with aforementioned kits and will contact customers to arrange for an update to affected systems. If you have any questions about this corrective action program, please contact the Service Support Department, Neusoft Medical Systems Co. Ltd. at nms-service@neusoft.com For questions regarding this recall call 425-487-7665.

Device

NeuViz 16 MultiSliced CT Scanner System and NeuViz Dual series CT Scanner System
  • Modelo / Serial
    NeuViz 16 system Serial numbers:  N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, N16E100023, N16E110016, N16E110023, N16E110026, N16E110027, N16E110040, N16E110053, N16E120016, N16E120022, N16E120020, N16E120023, N16E120024.   Neuviz Dual Serial numbers:  400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR090003, NDHR090012, and NDHR090013.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico.
  • Descripción del producto
    NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 || 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.
  • 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