Recall Z-1373-2011 · EHD Unit, X-Ray, Extraoral With Timer

Gendex Dental Systems

Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines, IL 60018; part number 110-0234G1 (domestic) and 110-0234G3 (international) The Orthoralix 8500 DDE Panoramic Dental X-Ray System is used as an extraoral source of x-rays for imaging of the dento-maxillofacial area.

Date	Feb 18, 2011 (initiated Dec 21, 2010)
Status	Terminated
Reason	The Automatic Exposure Control (AEC) feature located on the control panel of the Orthoralix 8500 Panoramic Dental X-Ray System was functional, but was subsequently disabled in units manufactured starting 5/17/10. North American units manufactured between 12/4/09 and 5/16/10 had functioning AEC buttons, but their manuals stated they were disabled. Units intended for International distribution bet
Root cause	Labeling Change Control
Action	Gendex sent a recall letter to their accounts on December 21, 2010, stating that the AEC button on the control panel was a non-functional feature that becomes illuminated upon activation and that Gendex would send them a kit to correct this issue and inactivate the button. A second letter was sent to the accounts on January 31, 2011, explaining that a corrective kit was no longer necessary, letting them know if the AEC feature was active or inactive for their system, and providing them with the appropriate user manual addendum for their system. Customers were asked to complete and return the
Quantity	574 systems
Distribution	Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, GA, CO, CT, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WA, and WI and the countries of Australia, Canada, Germany, New Zealand, Taiwan, and Vietnam.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K050255

ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4
Gendex Dental Systems, Mar 17, 2005