# FDA recall Z-1283-2022

> **CardioTek BV** · Class II · device recall initiated 2022-04-25.

## 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

- **Recall number:** Z-1283-2022
- **Recalling firm:** CardioTek BV
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2022-04-25
- **Report date:** 2022-06-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maastricht-Airport, Netherlands

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1283-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1283-2022. Source: US FDA. Licensed CC0.

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