System, X-ray, Extraoral Source, Digital

Villa Sistemi Rotograph EVO 3D X-ray

It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).

CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110

Units device head descended unexpectedly

CS 8100 3D, CATALOG # (s): 5311162, 5311188.

Units device head descended unexpectedly

The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize ex

An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Vantage Panoramic X-Ray unit to continue moving vertically despite the release of the movement control button (i.e. failure to stop").

Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Gendex Dental Systems, 901 West Oakton Street, Des Plaines, IL 60018.

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.

Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation.

faulty calibration

i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam

Incorrect scatter information in the manual.

Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging

Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.

DEXIS Titanium Intraoral Sensor

The sensor's look up calibration files were incorrectly programmed during manufacturing, which can result in the reduction of image quality.