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U.S. Department of Health and Human Services

Class 3 Device Recall ECG leadwire sets

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  Class 3 Device Recall ECG leadwire sets see related information
Date Initiated by Firm May 10, 2019
Create Date June 26, 2019
Recall Status1 Completed
Recall Number Z-1876-2019
Recall Event ID 82937
Product Classification Cable, transducer and electrode, patient, (including connector) - Product Code DSA
Product ECG leadwire sets:
REF/Catalog Number Description
2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in
2106389-002 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in
2106389-003 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 74 cm/ 29 in
2106389-004 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 130 cm/ 51 in
2106389-005 ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in
2106389-006 ECG Leadwire set, 5-lead, grouped, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in
2106390-001 ECG Leadwire set, 3-lead, grabber, AHA, 74 cm/ 29 in
2106390-002 ECG Leadwire set, 3-lead, grabber, AHA, 130 cm/ 51 in
2106390-003 ECG Leadwire set, 3-lead, grabber, IEC, 74 cm/ 29 in
2106390-004 ECG Leadwire set, 3-lead, grabber, IEC, 130 cm/ 51 in
2106391-001 ECG Leadwire set, 5-lead, grabber, AHA, 74 cm/ 29 in
2106391-002 ECG Leadwire set, 5-lead, grabber, AHA, 130 cm/ 51 in
2106391-003 ECG Leadwire set, 5-lead, grabber, IEC, 74 cm/ 29 in
2106391-004 ECG Leadwire set, 5-lead, grabber, IEC, 130 cm/ 51 in
2106391-005 ECG Leadwire set, 5-lead, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in
2106391-006 ECG Leadwire set, 5-lead, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in
2106393-001 ECG Leadwire set, 5-lead V2-6, grabber, AHA, 130 cm/ 51 in
2106393-002 ECG Leadwire set, 5-lead C2-6, grabber, IEC, 130 cm/ 51 in
2106393-003 ECG Leadwire set, 5-lead V2-6, grabber, AHA, 74 cm/ 29 in
2106393-004 ECG Leadwire set, 5-lead C2-6, grabber, IEC, 74 cm/ 29 in
2106397-001 ECG Leadwire set, 6-lead, grouped, grabber, AHA, 74 cm/ 29 in
2106397-002 ECG Leadwire set, 6-lead, grouped, grabber, AHA, 130 cm/ 51 in
2106397-003 ECG Leadwire set, 6-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in
2106398-001 ECG Leadwire set, 6-lead, grouped, grabber, IEC, 74 cm/ 29 in
2106398-002 ECG Leadwire set, 6-lead, grouped, grabber, IEC, 130 cm/ 51 in

The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.
Code Information product does not have lot or serial codes  REF/Catalog Number GTIN/UDI 2106389-001 00840682139960 2106389-002 00840682139779 2106389-003 none  2106389-004 none 2106389-005 00840682139786 2106389-006 none 2106390-001 00840682139687 2106390-002 00840682140232 2106390-003 none 2106390-004 none 2106391-001 00840682140799 2106391-002 00840682139830 2106391-003 none 2106391-004 none 2106391-005 00840682140348 2106391-006 none  2106393-001 00840682140287 2106393-002 none 2106393-003 00840682139885 2106393-004 none 2106397-001 00840682140522 2106397-002 00840682140461 2106397-003 00840682140041 2106398-001 none 2106398-002 none  
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		 ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
FDA Determined
Cause 2		 Process design
Action The firm, GE Healthcare, initiated a "URGENT MEDICAL DEVICE CORRECTION"letter dated 05/10/2019. The letter explained the reason for recall and provided the following safety instructions: The affected ECG trunk cables and leadwires may continue to be used for monitoring only. Discontinue use of the affected ECG trunk cables and leadwires for patients where an arrhythmia that might require defibrillation is foreseeable, and in these patients use unaffected ECG trunk cables and leadwires. If defibrillation turns out to be unexpectedly needed when the affected ECG trunk cables and leadwires are being used just for monitoring, follow the instructions below: 1) Disconnect ALL ECG leadwires from the patient. 2) Defibrillate the patient per hospital protocol. 3) If it is possible to monitor the patients rhythm using defibrillator ECG leadwires or pads please do so. If this is not possible, reconnect ECG leadwires after the patients rhythm has been defibrillated. The recalled products will be replaced. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce 58,045 units (31,108 US; 26937 OUS) in total
Distribution Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malta, Mauritius, Mexico, Moldova, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Palestine (state of), Panama, Poland, Qatar, Republic of Serbia, Romania, Russia, Saudia Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
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.
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