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U.S. Department of Health and Human Services

Class 2 Device Recall CareStream Dental

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  Class 2 Device Recall CareStream Dental see related information
Date Initiated by Firm September 18, 2012
Date Posted May 02, 2013
Recall Status1 Open3, Classified
Recall Number Z-1000-2013
Recall Event ID 64589
Product Classification Unit, x-ray, intraoral - Product Code EAP
Product CareStream Dental CS 2200 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.
Code Information ABYJ011, ABYJ012, ABYJ020 through ABYJ026, ACJY522, ACYJ004 through ACYJ007, ACYJ009 through ACYJ012, ACYJ014, ACYJ015, ACYJ017 through ACYJ023, ACYJ500 through ACYJ509, ACYJ517 through ACYJ521, ACYJ523 through ACYJ531, ACYJ533 through ACYJ536, ADYJ001 through ADYJ005, ADYJ007, ADYJ008, ADYJ011 through ADYJ013, ADYJ015 through ADYJ018, ADYJ020 through ADYJ032, ADYJ034 through ADYJ037, ADYJ039 through ADYJ049, ADYJ051, ADYJ054, ADYJ056, ADYJ061, ADYJ062, ADYJ064 through ADYJ067, ADYJ069 through ADYJ073, ADYJ075 through ADYJ082, AEYJ001 through AEYJ003, AEYJ005, AEYJ006, AEYJ008 through AEYJ010, AEYP003 through AEYP011, AEYP024 through AEYP026, AEYP028 through AEYP030, AFYP005 through AFYP008, AFYP012, AFYP014 through AFYP018, AFYP021, AFYP022, AGYP010, AGYP012, AGYP016, AGYP018 through AGYP020, AGYP022, AGYP025, AGYP027, AGYP028, AGYP030, AGYP031, AGYP033 through AGYP041, AGYP045, AGYP046, AGYP068, AGYP069, AGYP073, AGYP086, AGYP088, AGYP089, AGYP092, AJYP025, AJYP027, AKYP001, AKYP007, AKYP009.
Recalling Firm/
Manufacturer
Trophy Sas
4 Rue Pelloutier
Croissy Beaubourg France
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 167 installed in the US
Distribution USA Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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