BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1060-2019 · Initiated February 22, 2019

    Recall

    Recall Number
    Z-1060-2019
    Event Number
    82272
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IKD
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 22, 2019
    Terminated
    August 19, 2020
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    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.

    Action

    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.

    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.

    Quantity

    288 devices (23 US, 265 OUS)