FDA-Device2022-06-29Class II
CardioTek EP-TRACER Software V2.x.
CardioTek BV
Hazard
Device did not pass electrical safety testing for adequate insulation.
Sold states
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.
Affected count
146 units
Manufactured in
Amerikalaan 70, Maastricht-Airport, Netherlands
Products
CardioTek EP-TRACER Software V2.x.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1283-2022Don't want to check this manually?
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