Recall Z-1095-2013 ยท EAP Unit, X-Ray, Intraoral
Trophy Sas
CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
| Date | May 2, 2013 (initiated Sep 18, 2012) |
| Status | Terminated |
| Reason | There have been approximately 2% of the x-ray generators manufactured between February 2012 and November 2012 returned due to errors. These generators showed the type of defect that indicates poor contact of HT transformer power pin. The defect is a bent connector associated with the generator. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Trophy, A Carestream Dental Company, - A Subsidiary of Carestream Health Inc. The Center for Devices (CDRH) understands that the corrective action plan (CAP) involving 167 units will consist of implementing rework procedure TL008, which describes the procedure for a bending the metallic strip the female connector to insure strong connection with the male counterpart. The CAP appears to adequately address the problem and is hereby approved For further questions please call (585) 781-1997. |
| Quantity | 167 installed in the US |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.