FDA recall Z-1283-2022

Product

CardioTek EP-TRACER Software V2.x.

Reason for recall

Device did not pass electrical safety testing for adequate insulation.

Distribution

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.

Key facts

Status

Completed

Initiation date

2022-04-25

Report date

2022-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maastricht-Airport, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1283-2022