Recall Z-1559-2011 ยท EHD Unit, X-Ray, Extraoral With Timer
Gendex Dental Systems
Wall Mounting Plate, an accessory to the Gendex eXpert DC (REF 110-0205G1) and 765DC (REF 110-0155G1)Intraoral X-Ray Systems; Gendex Dental Systems, Des Plaines, IL USA The wall mounting plate is used to install the Master Control unit of the X-ray system to two wooden wall studs spaced at 16", or to a wall supported by steel studs.
| Date | Mar 4, 2011 (initiated Dec 20, 2010) |
| Status | Terminated |
| Reason | The X-Ray unit may break loose from the mounting plate and fall off the wall due to defects in the mounting plate. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Gendex, sent an "URGENT MEDICAL DEVICE FIELD CORRECTION" letter dated December 20, 2010 to their customers. A revised notification letter dated January 20, 2011, was sent to the customers providing further clarification on instruction to correct the problem, as well as a template for end user notification. The letters described the product, problem and actions to be taken. The customers were instructed to contact their customers, inform them of the issue and replace the wall-mounting plate. The customers were also instructed to complete and return the attached acknowledgement form |
| Quantity | 34 wall plates |
| Distribution | Worldwide distribution: USA and countries including: Australia, Canada and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992610 | GENDEX 765DC, MODEL 110-0154 Dentsply Intl., Sep 7, 1999 |