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.
FDA Recall Z-1548-2009 · Posted 2009-07-17
Recalling FirmGendex Dental Systems
Recall StatusTerminated
Product CodeMUH
Date Initiated2009-03-06
Date Terminated2011-01-07
Product Quantity1,256 units
Reason for Recall
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.