# FDA recall Z-1060-2019

> **GE Healthcare, LLC** · Class III · device recall initiated 2019-02-22.

## Product

Integrated ECG cable with 3-lead leadwires labeled as the following:      1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED  GRABBER LEAD WIRE, AHA, 3.6 M/12 FT;      2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED  GRABBER LEAD WIRE, IEC, 3.6 M/12 FT    Product Usage:  The reusable ECG trunk cable enables ECG monitoring with GE monitoring equipment requiring rectangular 11-pin connector cable. These accessories are indicated for use by qualified medical personnel only.

## Reason for recall

The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient.

## Distribution

Worldwide Distribution - US Nationwide to AK, KS, MA, MA, ME, NJ, NJ, NM, NY, TX.    Distributed worldwide to Chile, Finland, France, Germany, Italy, Korea (Republic Of), Russia, Spain, Sweden.

## Key facts

- **Recall number:** Z-1060-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-22
- **Report date:** 2019-04-03
- **Termination date:** 2020-08-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1060-2019

## Citation

> AI Analytics. FDA recall Z-1060-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1060-2019. Source: US FDA. Licensed CC0.

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