# FDA recall Z-3109-2017

> **Leonhard Lang Medizintechnik GmbH** · Class I · device recall initiated 2017-08-08.

## Product

Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion.    Product Usage:  Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.      Used with automated external defibrillators

## Reason for recall

Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.

## Distribution

Worldwide distribution. US distribution in the states of : FL & TX.  Austria, China,  France, Germany, Greece, Hungary, India, Italy, Panama, Philippines, Poland, Saudi Arabia, Serbia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-3109-2017
- **Recalling firm:** Leonhard Lang Medizintechnik GmbH
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-08
- **Report date:** 2017-09-20
- **Termination date:** 2020-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Innsbruck, N/A, Austria

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3109-2017

## Citation

> AI Analytics. FDA recall Z-3109-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3109-2017. Source: US FDA. Licensed CC0.

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