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U.S. Department of Health and Human Services

Class 3 Device Recall Integrated ECG cable

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  Class 3 Device Recall Integrated ECG cable see related information
Date Initiated by Firm February 22, 2019
Create Date March 26, 2019
Recall Status1 Terminated 3 on August 19, 2020
Recall Number Z-1060-2019
Recall Event ID 82272
Product Classification Cable, electrode - Product Code IKD
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.
Code Information 1. Catalog Number 2106309-001, GTIN 00840682137928;   2. Catalog Number 2106309-002, GTIN 00840682137829
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by 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.
Quantity in Commerce 288 devices (23 US, 265 OUS)
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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