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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 Posted May 02, 2013
Recall Status1 Open
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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