CLASS II Device recall · Reported 8 May 2013 · FDA Enforcement Report

CareStream Dental CS 2100 X-ray system recalled by Trophy Sas

Trophy Sas is recalling CareStream Dental CS 2100 X-ray system, distributed nationwide in the US. The recall was initiated on 18 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesABYJ011 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

Quantity recalled167 installed in the US

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0999-2013
FDA event ID: 64589
Recalling firm: Trophy Sas, Croissy Beaubourg
Classification: Class II
Status: Terminated
Recall initiated: 18 Sep 2012
FDA classified: 2 May 2013
Reported: 8 May 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

18 Sep 2012	Recall initiated by company
2 May 2013	Classified by FDA	+226 days
8 May 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

CareStream Dental CS 2100 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.

Where it was distributed

USA Nationwide Distribution

Nationwide

Questions about this recall

Is CareStream Dental CS 2100 X-ray system recalled?

Yes. Trophy Sas recalled CareStream Dental CS 2100 X-ray system on 18 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0999-2013.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

USA Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Trophy Sas

All 5

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Device	CLASS II	CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿ recalled	Trophy SAS	Other	N/A
8 May 2013Device	CLASS II	CareStream Dental CS 2200 X-ray system recalled by Trophy Sas	Trophy Sas	Device Malfunction	Nationwide
8 May 2013Device	CLASS II	CareStream Dental Kodak 2100 Intraoral X-ray system recalled	Trophy Sas	Device Malfunction	Nationwide
8 May 2013Device	CLASS II	CareStream Dental Kodak 2200 Intraoral X-ray system recalled	Trophy Sas	Device Malfunction	Nationwide

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