Orthoralix 8500 DDE Panoramic Dental X-Ray System; Extraoral x-ray unit with timer; Gendex Dental Systems, Des Plaines,

FDA device recall Z-1373-2011 · posted 2011-02-18 · Terminated

Recall details

Recalling firm

Gendex Dental Systems

Reason for recall

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

Action taken

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 required Acknowledgement Form by fax to 215-997-5665 or e-mail: regulatoryaffairs@gendex.com. For questions regarding this recall call 800-323-8029.

Root cause

Labeling Change Control

Status

Terminated

Product code

EHD

Quantity affected

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 A

Date initiated

2010-12-21

Date posted

2011-02-18

Date terminated

2011-11-09

Location

Des Plaines, IL

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