Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. 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. In addition, customers were asked to complete and return an Acknowledgement Form by fax to 1-84.įurther questions should be directed to the Gendex Technical Support team at 1-88.ġ A record in this database is created when a firm initiates a correction or removal action.
The noticed described the issue and provided a software update directed to fixing the problem. Gendex issued an "Urgent Medical Device Report" dated Mato the direct account dealers of the affected device via first class mail. 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. Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images.
KaVo Dental offers support for Gendex via phone, support requests and live support through remote assistance. VixWin and VixWin Platinum makes it easy for users to take full command of their radiographs. It integrates with existing practice management environments, imaging and other dentistry hardware. Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2 Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018. Gendex VixWin Platinum is imaging software for dentists that provides X-ray, radiography and automated image-mounting modules. System, image processing, radiological - Product Code MUH Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.Class 2 Device Recall Gendex VixWin Platinum Imaging Software With cutting-edge tools and powerful features, Gendex VixWin Platinum software yields detailed images and the latest innovations every practice can. Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2 Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018. It was initially added to our database on. The latest version of VixWin Platinum is currently unknown. It was checked for updates 31 times by the users of our client application UpdateStar during the last month. In addition, customers were asked to complete and return an Acknowledgement Form by fax to 1-84.įurther questions should be directed to the Gendex Technical Support team at 1-88.ġ A record in this database is created when a firm initiates a correction or removal action. VixWin Platinum is a Shareware software in the category Miscellaneous developed by Gendex. Do you have VixWin Platinum Dont want to switch your imaging software Apex Dental Sensors are nearly 1/2 the cost of a Gendex GXS-700 Dental Sensor. See how VixWin Platinum can accelerate the digital radiology workflow in. With powerful tools, such as the Optimizer and Spine Compensation features, clinicians can easily enhance image clarity and definition for improved diagnostics. Diagnostic software / for dental imaging VIXWIN PLATINUM Gendex Dental Systems. Gendex issued an "Urgent Medical Device Report" dated Mato the direct account dealers of the affected device via first class mail. VixWin and VixWin Platinum makes it easy for users to take full command of their radiographs.
Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2 Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018. Class 2 Device Recall Gendex VixWin Platinum Imaging Software French, German, Italian, Japanese, Korean, Norwegian, Polish, Portuguese, Romanian, Russian, Spanish, Swedish, Turkish, Ukrainian.