Jul

2009

Cl Il Gendex VixWin Platinum Imaging Software

Company: Gendex Dental Systems
Date of Enforcement Report 7/22/2009
Class:ll

PRODUCT
Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images. Recall # Z-1548-2009

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.

RECALLING FIRM/MANUFACTURER
Gendex Dental Systems, Des Plaines, IL, by letter dated March 6, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1256 units

DISTRIBUTION
Nationwide

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl Il Gendex VixWin Platinum Imaging Software

Amy Sellers

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