Events

Recall of Device Recall NeuViz 64 Multislice CT Scanner System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Neusoft Medical Systems Co., Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77608
  • Event Risk Class
    Class 2
  • Event Number
    Z-3044-2017
  • Event Initiated Date
    2017-05-19
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156762
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, x-ray, tomography, computed - Product Code JAK
  • Reason
    Software defect.
  • Action
    Neusoft Medical Systems will bring defect into compliance: The defect will be remedied by updating software. Field Change Order I related to software updated will be released to the affected systems in ' Aug, 2017. The affected systems will be upgraded with updated software in the field free of char e in 6 months after the FCO release.

Device

Device Recall NeuViz 64 Multislice CT Scanner System
  • Model / Serial
    NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide distribution
  • Product Description
    Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: || NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, || NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version || Product Usage: || The Multi-Slice 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. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
  • Manufacturer
    Neusoft Medical Systems Co., Ltd.

Manufacturer

Neusoft Medical Systems Co., Ltd.
  • Manufacturer Address
    Neusoft Medical Systems Co., Ltd., NO. 16 Shiji Road, Hunnan Industrial Area, Shenyang China
  • Source
    USFDA