Gendex Vixwin Platinum
admin 13.10.2019
Class 2 Device Recall Gendex VixWin Platinum Imaging Software Date Initiated by Firm March 06, 2009 Date Posted July 17, 2009 Recall Status Terminated on January 07, 2011 Recall Number Z-1548-2009 Recall Event ID 510(K)Number Product Classification - Product Code Product 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. Code Information Software versions 1.0, 1.1 and 1.2. Recalling Firm/ Manufacturer Gendex Dental Systems 901 W Oakton St Des Plaines IL For Additional Information Contact Ms.
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 Software design 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. Quantity in Commerce 1,256 units Distribution Nationwide Distribution. Total Product Life Cycle 1 A record in this database is created when a firm initiates a correction or removal action.
Gendex's VixWin™ Platinum combines cutting edge tools and powerful features that yield crisp, clearly detailed images within an environment of accelerated workflow. Intuitive icons and toolbars in VixWin™ Platinum allow users to quickly identify and access tools for image applications, reducing task times and increasing productivity. Do you have VixWin Platinum? Don’t want to switch your imaging software? Ei Dental Sensors work with VixWin Platinum.
Gendex Vixwin Platinum Multilic
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. 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.
Gendex Vixwin Platinum Multilic
510(K) Database.