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
    62481
  • Event Risk Class
    Class 2
  • Event Number
    Z-2083-2012
  • Event Initiated Date
    2012-06-08
  • Event Date Posted
    2012-07-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110741
  • 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
    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
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- North Carolina, Ohio, and Texas.
  • 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