CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is for

FDA device recall Z-0999-2013 · posted 2013-05-02 · Terminated

Recall details

Recalling firm

Trophy Sas

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.

Action taken

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

Status

Terminated

Product code

EAP

Quantity affected

167 installed in the US

Distribution

USA Nationwide Distribution

Date initiated

2012-09-18

Date posted

2013-05-02

Date terminated

2017-05-02

Location

Croissy Beaubourg, France