Recall Z-1358-2012 ยท EHD Unit, X-Ray, Extraoral With Timer
Gendex Dental Systems
Gendex eXpert DC Intraoral Dental X-Ray System Device is to be used as an extra-oral source of X-Rays in Dental Radiography
| Date | Apr 2, 2012 (initiated Dec 29, 2011) |
| Status | Terminated |
| Reason | Improper hardware was used during installation of the eXpert DC Intraoral X-Ray system units causing drifting of the tubehead assembly. |
| Root cause | Nonconforming Material/Component |
| Action | Gendex Dental Systems sent a Urgent Medical Device Correction letter dated December 29, 2011, to both affected customers. The Customers were provided background information and details on how the nonconforming installations of the devices would be corrected. Gendex Dental Systems apologizes for any inconvenience caused by this issue, and request your corporation as we correct this problem. The customers were instructed to complete and return the Acknowledgement Form upon receipt of the recall notification letter and fax to (215) 997-5665. For further questions please call (215) 954-0365 |
| Quantity | 52 |
| Distribution | USA including the states of Iowa and Illinois. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992610 | GENDEX 765DC, MODEL 110-0154 Dentsply Intl., Sep 7, 1999 |