Recall Z-1020-2013 ยท EAP Unit, X-Ray, Intraoral
DeGotzen
DeGotzen XRay unit XGenus Dental X-ray unit.
| Date | Apr 17, 2013 (initiated Sep 26, 2012) |
| Status | Terminated |
| Reason | It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification |
| Root cause | Radiation Control for Health and Safety Act |
| Action | DeGotzen will add new labeling or change existing labeling to correct for the 5 mentioned deficiencies. This correction of the noncompliant products must be made at no cost to the customers. For further questions please call 800-289-6367 ext. 390. |
| Quantity | 159 units |
| Distribution | US (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.