CardioTek BV recalls CardioTek EP-TRACER Software V2.x.
- Recall date
- April 25, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1283-2022
- FDA classification
- Class II
- Brand / firm
- CardioTek BV
- Sold / distributed
- 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 Arab…
Why it was recalled
Device did not pass electrical safety testing for adequate insulation.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CardioTek EP-TRACER Software V2.x.
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