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
    73741
  • Event Risk Class
    Class 2
  • Event Number
    Z-1573-2016
  • Event Initiated Date
    2016-03-24
  • Event Date Posted
    2016-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144838
  • 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
    The following issues are found in neuviz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) during the filming operation on mx 16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. if the operator fails to copy the current patient's images before pasting, a previous patient's image may be present in the clipboard and be.
  • Action
    Affected consignees will be notified of the recall via letter on March 24, 2016. Mandatory Field Change Order and FCO kits will be released to all affected systems in June, 2016.

Device

Device Recall NeuViz 16 MultiSlice CT Scanner System
  • Model / Serial
    Serial Numbers: N16E090002, N16E090003, N16E090007, N16E090008, N16E090010, N16E100023, N16E110023, N16E110026, N16E120016, N16E120023, N16E120052, N16E120053, N16E130012, N16E130038, N16E130045, N16E140008, N16E140007, N16E140012, N16E140017, N16E140020, N16E140029, N16E140056, N16E140057, N16E140058, N16E150004, N16E150014, N16E150013, N16E150015, N16E150025, N16E150024, N16E150027, N16E150038, N16E150039, N16E150040, N16E100017, N16E140030 and N16E140031
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    NC, OH, NE, SC, TX, LA, PR, MO, FL, CT
  • Product Description
    NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 || 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.
  • 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., No. 2 Xiu xiu Street, Hunnan; Sujiatun, Shenyang China
  • Source
    USFDA