# FDA recall Z-2657-2017

> **CardioTek BV** · Class II · device recall initiated 2017-04-13.

## Product

CardioTek EP-TRACER Software V1.x and V2.0    The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

## Reason for recall

Software bug which allows parameters to be changed unintentionally during use.

## Distribution

Worldwide Distribution: US (nationwide) to states of: CA, IL, OH, and MN; and countries of: Albania, Algeria, Argentina, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, Cuba, Czech Rep, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Monaco, Morocco, Netherlands, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Rep. Dominicana, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Trinidad & Tobago, Turkey, United Arab Emirates, United Kingdom, Venezuela and Vietnam.

## Key facts

- **Recall number:** Z-2657-2017
- **Recalling firm:** CardioTek BV
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2017-04-13
- **Report date:** 2017-07-12

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2657-2017

## Citation

> AI Analytics. FDA recall Z-2657-2017. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2657-2017. Source: US FDA. Licensed CC0.

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