Events

Rappel de Device Recall NeuViz 64 Multislice CT Scanner System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Neusoft Medical System Co.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    71306
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1693-2015
  • Date de mise en oeuvre de l'événement
    2014-03-08
  • Date de publication de l'événement
    2015-06-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137271
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, x-ray, tomography, computed - Product Code JAK
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    NeuViz 16/64 Series
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    Neusoft NeuViz 64 Multi-slice CT Scanner System
  • Manufacturer
    Neusoft Medical System Co

Manufacturer

Neusoft Medical System Co
  • Adresse du fabricant
    Neusoft Medical System Co, 14425 Torrey Chase Blvd Ste 100, Houston TX 77014-1637
  • Source
    USFDA