Reported May 8, 2013 · Terminated

CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is…

Trophy Sas

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Trophy Sas · 4 Rue Pelloutier · Croissy Beaubourg · N/A

Is this the product you have?

  • CareStream Dental
  • CS 2200 X-ray system Product UsageThe expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures
Lot codes and dates
  • 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
Amount recalled
167 installed in the US

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 2, 2017 · Data as of Sep 19, 4:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.