Recall Z-0009-2015 ยท EHD Unit, X-Ray, Extraoral With Timer
Gendex Corp
eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
| Date | Oct 2, 2014 (initiated Aug 12, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Gendex sent a Recall Notification Letter, dated August 12, 2014 and a second Communication Notification letter on September 22, 2014 to all affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Gendex Customer Service at 1-800-323-8029. |
| Quantity | 651 |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Europe, Canada, Australia, China, Russia, Taiwan, Singapore, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992610 | GENDEX 765DC, MODEL 110-0154 Dentsply Intl., Sep 7, 1999 |