Events

Rappel de Device Recall NeuViz 16 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 Philips And Neusoft Medical Systems Co., Ltd..

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
    62481
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2083-2012
  • Date de mise en oeuvre de l'événement
    2012-06-08
  • Date de publication de l'événement
    2012-07-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110741
  • 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
    One of the four screws that secure the oil-accumulator to the x-ray tube pulled out in the neuviz 16 ct scanner, which caused the oil-accumulator to detach.
  • Action
    Philips Healthcare North America Company sent an "Urgent Device Correction NeuViz 16 X-Ray Tube Oil-accumulator Detached" letter and attachments of Annex A Method to Identify Affected Products and Annex B Instruction for Mechanic, dated June 14, 2012, to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to follow the instructions on Annex A and Annex B. Philips and Neusoft Medical Systems planned to release the mandatory Field Change Order (FCO) and FCO kits to all customers by the end of June 2012. If you have any questions about this corrective action program, please contact the Service Support Department, Neusoft Medical Systems, Co., LTD by e-mail to NMS-SERVICE@NEUSOFT.COM

Device

Device Recall NeuViz 16 MultiSlice CT Scanner System
  • Modèle / numéro de série
    Serial No.: N16E0 90002, N16E0 90003, N16E0 90004, N16E0 90007, N16E0 90008, N16E0 90010, N16E1 00015, N16E1 00017, N16E1 00023, N16E1 10016, N16E1 10023, N16E1 10026, N16E1 10027, N16E1 10040, and N16E1 10053.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- North Carolina, Ohio, and Texas.
  • Description du dispositif
    NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. || The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".
  • Manufacturer
    Philips And Neusoft Medical Systems Co., Ltd.

Manufacturer

Philips And Neusoft Medical Systems Co., Ltd.
  • Adresse du fabricant
    Philips And Neusoft Medical Systems Co., Ltd., 16 Century Road, Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning China
  • Source
    USFDA