CareStream Dental Kodak 2100 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.
FDA Recall Z-1094-2013 · Posted 2013-05-02
Recalling FirmTrophy Sas
Recall StatusTerminated
Product CodeEAP
Date Initiated2012-09-18
Date Terminated2017-05-02
Product Quantity167 installed in the US
Reason for Recall
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.
Firm 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.
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
USA Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.