Recall Z-1548-2009 ยท MUH System, X-Ray, Extraoral Source, Digital
Gendex Dental Systems
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.
| Date | Jul 17, 2009 (initiated Mar 6, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 1,256 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060178 | VIX WIN PRO Gendex Dental Systems, Mar 10, 2006 |