Z-1095-2013Class II

CareStream Dental Kodak 2200 Intraoral X-ray system

Name: Z-1095-2013 CareStream Dental Kodak 2200 Intraoral X-ray system
Creator: Trophy Sas
Published: 2012-09-18
License: https://open.fda.gov/license/

Trophy / initiated 2012-09-18 / Terminated / root cause: manufacturing process

FDA source

Trophy Sas began a recall of CareStream Dental Kodak 2200 Intraoral X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic... on 2012-09-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1095-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-18
Posted: 2013-05-02
Terminated: 2017-05-02
Recalling firm: Trophy
Product: 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.
Product code: EAP Unit, X-Ray, Intraoral
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 167 installed in the US
Distribution: USA Nationwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1095-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0999-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-05-02
Z-1000-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-05-02
Z-1094-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-05-02
Z-1095-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-05-02

Product code EAP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)