Recall Z-1248-2011 ยท EHD Unit, X-Ray, Extraoral With Timer
Gendex Dental Systems
Gendex Dental Systems, Gendex eXpert DC Intraoral X-Ray System; a dental x-ray system; Model 110-0205G1, catalog number EXPERTDC75NA
| Date | Feb 15, 2011 (initiated Dec 17, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | Gendex sent a Urgent Medical Device Field Correction letter dated December 17, 2010 to the consignee, informing them that the x-ray units were installed with improper sized lag bolts and requesting that they contact Gendex Customer Service at 1-800-323-8029 to complete the field correction. |
| Quantity | 5 units |
| Distribution | California |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992610 | GENDEX 765DC, MODEL 110-0154 Dentsply Intl., Sep 7, 1999 |