Events

Recall of Device Recall Gendex VixWin Platinum Imaging Software

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

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
    51485
  • Event Risk Class
    Class 2
  • Event Number
    Z-1548-2009
  • Event Initiated Date
    2009-03-06
  • Event Date Posted
    2009-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80517
  • 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, image processing, radiological - Product Code MUH
  • Reason
    There is a compatibility issue when the vixwin platinum versions 1.0/1.1/1.2 software is used in conjunction with easy dental, practiceworks, eaglesoft and softdent practice management software, resulting in patient files that may contain images that are mixed between patients.
  • Action
    Gendex issued an "Urgent Medical Device Report" dated March 6, 2009 to the direct account dealers of the affected device via first class mail. The noticed described the issue and provided a software update directed to fixing the problem. In addition, customers were asked to complete and return an Acknowledgement Form by fax to 1-847-718-0601. Further questions should be directed to the Gendex Technical Support team at 1-888-275-5286.

Device

Device Recall Gendex VixWin Platinum Imaging Software
  • Model / Serial
    Software versions 1.0, 1.1 and 1.2.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018. || Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images.
  • Manufacturer
    Gendex Dental Systems

Manufacturer

Gendex Dental Systems
  • Manufacturer Address
    Gendex Dental Systems, 901 W Oakton St, Des Plaines IL 60018-1843
  • Source
    USFDA