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
    64783
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1165-2013
  • Date de mise en oeuvre de l'événement
    2013-03-04
  • Date de publication de l'événement
    2013-04-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117085
  • 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
    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.
  • Action
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: California, Connecticut, North Carolina, Nebraska, Ohio, South Carolina, Texas, and Puerto Rico.
  • Description du dispositif
    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.
  • Adresse du fabricant
    Philips And Neusoft Medical Systems Co., Ltd., 16 Century Road, Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning China
  • Source
    USFDA