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Trophy Sas recalls CareStream Dental CS 2100 X-ray system Product Usage: The expected usage (intended use) for all of these products is
Recalled May 8, 2013 · FDA recall Z-0999-2013 · 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. · FDA Class II
Units
167 installed in the US
Sold at
USA Nationwide Distribution
Description
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.
Product
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.
Manufacturer(s)
Trophy Sas
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →