Events

Retiro De Equipo (Recall) de Device Recall NeuViz 64 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 Neusoft Medical System Co.

¿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
    71306
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1693-2015
  • Fecha de inicio del evento
    2014-03-08
  • Fecha de publicación del evento
    2015-06-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137271
  • 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 a-plane compensator is made of teflon which will become fragile due to x-ray exposure passing through it. the thinnest part of the compensator is subject to radiation degradation and as a result has been found to fail prematurely. failure is indicated by pin or ring artifact in the image.
  • Acción
    Neusoft planned action: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Neusoft Medical Systems Co., Ltd will implement actions to monitor the exposures of the tube and when the exposure number is close to 300,000 seconds, the A-plane compensator will be replaced. The Food and Drug Administration (FDA) district office coordinator should be notified when the last A-plane compensator is replaced. 3. The Customer Information Letter has been sent to customers as a corrective action. The maximum exposure number of 5 US systems is 191830 seconds as of Apr.20, 2015, so the firm will monitor the data continuously and replace the A-plane compensators before the defined threshold. 4. Neusoft will replace all compensators that have exceeded the 300,000 seconds free of charge and will replace all compensators that fail during warranty and the compensators failed less than 300,000 seconds though out of warranty free of charge. You may proceed or continue with implementation of the CAP (subject to the conditions noted above) For further questions please call (281) 453-1205

Device

Device Recall NeuViz 64 Multislice CT Scanner System
  • Modelo / Serial
    NeuViz 16/64 Series
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Distribution including Puerto Rico and to the states of : IL, MA, TX and SC., and to the countries of : China, Malaysia, Lebanon, Ecuador, Egypt, United Arab Emirates,Kazashstan, Tunisia, Angola, Brazil, Uzbekistan, Lebanon, Cote D' ivoire, South Africa, Montenegro and Tajikistan.
  • Descripción del producto
    Neusoft NeuViz 64 Multi-slice CT Scanner System
  • Manufacturer
    Neusoft Medical System Co

Manufacturer

Neusoft Medical System Co
  • Dirección del fabricante
    Neusoft Medical System Co, 14425 Torrey Chase Blvd Ste 100, Houston TX 77014-1637
  • Source
    USFDA