Events

Recall of Device Recall NeuViz 16 MultiSlice CT Scanner System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips And 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
    58582
  • Event Risk Class
    Class 2
  • Event Number
    Z-2241-2011
  • Event Initiated Date
    2011-02-09
  • Event Date Posted
    2011-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99626
  • 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
    Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image.
  • Action
    Neusoft Medical Systems sent an Urgent Device Correction Notification letter dated February 9, 2011, via certified mail to their distributor NEUISYS. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to discontinue use of combined images. Instead, use MPR Batch for diagnostic reviews until the planned upgrade is provided to the product. Neusoft Medical System and Philips Medical System released the mandatory Field Change Order (FCO) by March 31, 2011. All nine affected systems will be updated with aforementioned kits in six months after the release. Consignees were instructed to contact Service Support Department by e-mail to nms-service@neusoft.com

Device

Device Recall NeuViz 16 MultiSlice CT Scanner System
  • Model / Serial
    Serial Numbers:   N16E090002, N16E090003, N16E090004, N16E090007, N16E090008, N16E090010, N16E100015, N16E100017, and N16E100023.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including CA, GA, LA, NC, OH, TN and TX.
  • Product Description
    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.
  • Manufacturer Address
    Philips And Neusoft Medical Systems Co., Ltd., 16 Century Road, Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning China
  • Source
    USFDA