Events

Recall of Device Recall NeuViz Dual series Computed Tomography (CT) Scanner System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Neuisys, LLC.

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
    49012
  • Event Risk Class
    Class 2
  • Event Number
    Z-2237-2010
  • Event Initiated Date
    2008-07-21
  • Event Date Posted
    2010-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72515
  • 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
    Computed Tomography X-Ray System - Product Code JAK
  • Reason
    The reference lines for image generated for a surview scan may appear in the incorrect position in the "film" display mode.
  • Action
    On 07/21/2008, NEUISYS Imaging Systems Solutions distributor in Greensboro, NC began sending the URGENT DEVICE CORRECTION letter on behalf of Philips and NeuSoft Medical Systems (PNMS), Co., Ltd in China. The letter informs the consignees that there is potential safety problem in the NeuViz Dual series CT scanners due to the malfunction of "Incorrect Reference Line in the Film". When a "Head first, Couch out" or a "Feet first, Couch in" Surview scan is started then paused midstream, the image generated is what the doctor expects, but the reference lines appear in the incorrect position in "FILM" display mode. The acquired images accurately represent the exact positions planned on the original view. The incorrect/unmatched reference line in film may result in incorrect diagnosis. The consignees are advised not to stop or pause during Surview acquisition while PNMS in China will provide the updated software patch to all affected systems free of charge. The Field Change Order #FCOP-08-CT-NMS-008 SP4 will be implemented by NEUISYS Imaging Systems Solutions in Greensboro, NC., who is a distributor for PNMS. Consignees are advised to e-mail Service Support Department of PNMS at helpdesk@pnms.neusoft.com regarding the recall.

Device

Device Recall NeuViz Dual series Computed Tomography (CT) Scanner System
  • Model / Serial
    Serial Number:  400562, 400563, 400626, NDH009EI, NDH011El, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR08002, and NDHRO80003.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. || Intended to produce cross-section images of head and body by || computer reconstruction of X-ray transmission data taken at different || angles.
  • Manufacturer
    Neuisys, LLC

Manufacturer

Neuisys, LLC
  • Manufacturer Address
    Neuisys, LLC, 1500 Pinecroft Rd Ste 212, Greensboro NC 27407-3808
  • Manufacturer Parent Company (2017)
    Neuisys Llc
  • Source
    USFDA