Integrated ECG cable with 3-lead leadwires labeled as the following: 1…

Date

April 3, 2019

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

GE Healthcare, LLC

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

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 pattern

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.

Quantity

288 devices (23 US, 265 OUS)

Codes and lots

1. Catalog Number 2106309-001, GTIN 00840682137928; 2. Catalog Number 2106309-002, GTIN 00840682137829

Recall started

Feb. 22, 2019

Device type

Cable, Electrode

Root cause (FDA)

Under Investigation by firm

What the company told customers

Consignees were initially notified via telephone call on about 02/22/2019 and followed up with an "URGENT MEDICAL DEVICE CORECTION" letter. Instructions included to immediately stop use of the affected Integrated ECG cables and quarantine any on hand. GE Healthcare will replace all affected cables at no cost and a GE Healthcare representative will contact each customer to arrange for the collection of the affected cables and provide replacement of new cables. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171.

Recall number

Z-1060-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1060-2019. The agency record governs; check it and the company before acting.