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.
FDA Recall Z-1060-2019 · Posted None
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Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeIKD
Date Initiated2019-02-22
Date Terminated2020-08-19
Product Quantity288 devices (23 US, 265 OUS)
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.
Firm 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.
Root Cause
Under Investigation by firm
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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