FDA-Device2013-05-08Class II
CareStream Dental Kodak 2100 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.
Trophy Sas
Hazard
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.
Sold states
USA Nationwide Distribution
Affected count
167 installed in the US
Manufactured in
4 Rue Pelloutier, Croissy Beaubourg, France
Products
CareStream Dental Kodak 2100 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1094-2013Don't want to check this manually?
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