Gendex 765DC, Model 110-0154

• • Terminated Z-0009-2015 FDA Class II ·initiated 12 Aug 2014

  Two (2) failures of the spring link components within the articulated arm assembly. The spring links broke during normal assembly process for the articulated arm during first cycle of the arm, prior to the 14lb tube head (full load) being installed onto the assembled articulated arm.

• • Terminated Z-1358-2012 FDA Unclassified (pre-2012) ·initiated 29 Dec 2011

  Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly.

• • Terminated Z-1559-2011 FDA Unclassified (pre-2012) ·initiated 20 Dec 2010

  The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate.

• • Terminated Z-1248-2011 FDA Unclassified (pre-2012) ·initiated 17 Dec 2010

  The intraoral x-ray systems were installed improperly with incorrect screws which allow the unit to pull away from the wall when the arm is fully extended. This condition may harm the patient.

510(k) Number

K992610 ↗

FDA Product Code

EHD

Device Class

Class II

Regulation

21 CFR Part 872.1800

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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