medical Class III Updated 2019-04-03

GE Healthcare, LLC recalls Integrated ECG cable with 3-lead leadwires labeled as the fo

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1. Catalog Number 2106309-001, GTIN 00840682137928; 2. Catalog Number 2106309-002, GTIN 00840682137829
View official government recall

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