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CardioTek BV recalls CardioTek EP-TRACER Software V2.x.
Recalled June 29, 2022 · FDA recall Z-1283-2022 · CardioTek BV
Hazard
Device did not pass electrical safety testing for adequate insulation. · FDA Class II
Units
146 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of CA, NY, NC and the countries of South Korea, Mexico, Kazakhstan, Netherlands, Spain, Germany, Finland, Poland, Israel, Turkey, Chile, Ecuador, Austria, Croatia, Sweden, United Kingdom, Colombia, Italy, Portugal, Canada, Saudi Arabia, Belgium, Slovenia, Brazil, Hungary, Malaysia, Uzbekistan.
Description
Device did not pass electrical safety testing for adequate insulation.
Product
CardioTek EP-TRACER Software V2.x.
Manufacturer(s)
CardioTek BV
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →