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U.S. Department of Health and Human Services

Class 2 Device Recall Gendex VixWin Platinum Imaging Software

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 Class 2 Device Recall Gendex VixWin Platinum Imaging Softwaresee related information
Date Initiated by FirmMarch 06, 2009
Date PostedJuly 17, 2009
Recall Status1 Terminated 3 on January 07, 2011
Recall NumberZ-1548-2009
Recall Event ID 51485
510(K)NumberK060178 
Product Classification System, image processing, radiological - Product Code MUH
ProductGendex 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.
Code Information Software versions 1.0, 1.1 and 1.2.
FEI Number 3004115000
Recalling Firm/
Manufacturer		 Gendex Dental Systems
901 W Oakton St
Des Plaines IL 60018-1843
For Additional Information ContactMs. Mari Lambert
847-736-4900
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionGendex 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.
Quantity in Commerce1,256 units
DistributionNationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MUH
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