Events

Recall of Device Recall NeuViz Dual Series Computed Tomography 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
    54638
  • Event Risk Class
    Class 2
  • Event Number
    Z-0846-2011
  • Event Initiated Date
    2010-02-10
  • Event Date Posted
    2011-01-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88867
  • 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
    NeuViz Dual Series Computed Tomography Scanner System - Product Code JAK
  • Reason
    Potential for the ct patient table top to become detached from the carrier due to missing washers.
  • Action
    Neusoft Medical Systems Co., China sent an URGENT DEVICE CORRECTION letter dated Feb. 10, 2010 to their distributor in NC. On 02/12/10, The distributor sent the same letter to their consignees. The firm informed this distributor that there was report of the four screws that secure the patient table top to the carrier that did not have the proper washers in place which caused the table top to detach. If the issue would reoccur, there is a potential for the table top to fall and cause patient injury. Customers were instructed to check the patient table top fixing. If it is found that the the assembly is improper customers were instructed to top using the product and contact local Service personnel for repair. Any customer can contact Service Support Department, Neusoft Medical Systems Co, LTD at nms-service@neusoft.com or Service Support Department at helpdesk@neusoft.com for questions about this recall.

Device

Device Recall NeuViz Dual Series Computed Tomography Scanner System
  • Model / Serial
    Part number: NeuViz Dual 989605651321.  SERIAL NUMBERS:  400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002, NDHR080003, NDHR080004, NDHR080007, NDHR080012, NDHR080021, NDHR080031, NDHR090003, and NDHR090012.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including NC
  • Product Description
    The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. || Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***". || Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles.
  • 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., Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning China
  • Source
    USFDA