GE Healthcare, LLC: ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2106305-004 ECG Trunk Cable, 3/5-lead, IEC, 1.2 m/4 ft. 2106306-001 ECG Trunk Cable, Neonatal, DIN 3-lead, AHA, 3.6 m/12 ft. 2106306-002 ECG Trunk Cable, Neonatal, DIN 3-lead, AHA, 1.2 m/4 ft. 2106306-003 ECG Trunk Cable, Neonatal, DIN 3-lead, IEC, 3.6 m/12 ft. 2106306-004 ECG Trunk Cable, Neonatal, DIN 3-lead, IEC, 1.2 m/4 ft. 2106307-001 ECG Trunk Cable, 6-lead, AHA, 3.6 m/12 ft. 2106307-002 ECG Trunk Cable, 6-lead, AHA, 1.2 m/4 ft. 2106307-003 ECG Trunk Cable, 6-lead, IEC, 3.6 m/12 ft. 2106307-004 ECG Trunk Cable, 6-lead, IEC, 1.2 m/4 ft. 2106308-001 ECG Trunk Cable, 12-lead, AHA, 3.6 m/12 ft. 2106308-002 ECG Trunk Cable, 12-lead, AHA, 1.2 m/4 ft. 2106308-003 ECG Trunk Cable, 12-lead, IEC, 3.6 m/12 ft. 2106308-004 ECG Trunk Cable, 12-lead, IEC, 1.2 m/4 ft. 2106310-001 ECG Trunk Cable, 3/5-lead w/ESU filter, AHA, 3.6 m/12 ft. 2106310-002 ECG Trunk Cable, 3/5-lead w/ESU filter, IEC, 3.6 m/12 ft. 2106311-001 ECG Trunk Cable, 3/5-lead, AHA, 6 m/20 ft. 2106311-002 ECG Trunk Cable, 3/5-lead, IEC, 6 m/20 ft. The reusable ECG trunk cable enables ECG monitoring with GE monitoring equipment requiring rectangular 11-pin connector cable.

Recall number

Z-1875-2019

Recalling firm

GE Healthcare, LLC

Product

ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2106305-004 ECG Trunk Cable, 3/5-lead, IEC, 1.2 m/4 ft. 2106306-001 ECG Trunk Cable, Neonatal, DIN 3-lead, AHA, 3.6 m/12 ft. 2106306-002 ECG Trunk Cable, Neonatal, DIN 3-lead, AHA, 1.2 m/4 ft. 2106306-003 ECG Trunk Cable, Neonatal, DIN 3-lead, IEC, 3.6 m/12 ft. 2106306-004 ECG Trunk Cable, Neonatal, DIN 3-lead, IEC, 1.2 m/4 ft. 2106307-001 ECG Trunk Cable, 6-lead, AHA, 3.6 m/12 ft. 2106307-002 ECG Trunk Cable, 6-lead, AHA, 1.2 m/4 ft. 2106307-003 ECG Trunk Cable, 6-lead, IEC, 3.6 m/12 ft. 2106307-004 ECG Trunk Cable, 6-lead, IEC, 1.2 m/4 ft. 2106308-001 ECG Trunk Cable, 12-lead, AHA, 3.6 m/12 ft. 2106308-002 ECG Trunk Cable, 12-lead, AHA, 1.2 m/4 ft. 2106308-003 ECG Trunk Cable, 12-lead, IEC, 3.6 m/12 ft. 2106308-004 ECG Trunk Cable, 12-lead, IEC, 1.2 m/4 ft. 2106310-001 ECG Trunk Cable, 3/5-lead w/ESU filter, AHA, 3.6 m/12 ft. 2106310-002 ECG Trunk Cable, 3/5-lead w/ESU filter, IEC, 3.6 m/12 ft. 2106311-001 ECG Trunk Cable, 3/5-lead, AHA, 6 m/20 ft. 2106311-002 ECG Trunk Cable, 3/5-lead, IEC, 6 m/20 ft. The reusable ECG trunk cable enables ECG monitoring with GE monitoring equipment requiring rectangular 11-pin connector cable.

Status

Terminated

Initiated

2019-05-10

Posted

not on file

Terminated

2024-05-24

Reason

ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.

Root cause

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

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.

Lot, serial or model codes

Product does not have lot or serial numbers  REF/Catalog Number GTIN/UDI 2106305-001 00840682137775 2106305-002 00840682137898 2106305-003 none 2106305-004 none 2106306-001 00840682137843 2106306-002 00840682137737 2106306-003 none 2106306-004 none 2106307-001 00840682137836 2106307-002 00840682137751 2106307-003 none 2106307-004 none 2106308-001 00840682137713 2106308-002 00840682137812 2106308-003 none 2106308-004 none 2106310-001 00840682137935 2106310-002 none 2106311-001 00840682137676 2106311-002 none

510(k) numbers

not on file

PMA numbers

not on file

Product code

DSA

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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