Z-1548-2009

Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton...

Name: Z-1548-2009 Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton...
Creator: Gendex Dental Systems
Published: 2009-03-06
License: https://open.fda.gov/license/

Gendex Corp. / initiated 2009-03-06 / Terminated / root cause: software

FDA source

Gendex Dental Systems began a recall of 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... on 2009-03-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1548-2009
Status: Terminated
Initiated: 2009-03-06
Posted: 2009-07-17
Terminated: 2011-01-07
Recalling firm: Gendex Corp.
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.
Product code: MUH System, X-Ray, Extraoral Source, Digital
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.
Root cause tag: software
FDA root 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.
Product codes and lots: Software versions 1.0, 1.1 and 1.2.

Product code MUH

K060178Class IIVix Win ProGendex Dental Systems / cleared 2006-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)