Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton Street, Des P
FDA device recall Z-1548-2009 · posted 2009-07-17 · Terminated
Recall details
- Recalling firm
- Gendex Dental Systems
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUH
- Quantity affected
- 1,256 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-03-06
- Date posted
- 2009-07-17
- Date terminated
- 2011-01-07
- Location
- Des Plaines, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIX WIN PRO (K060178) | Gendex Dental Systems | 2006-03-10 |