Z-1876-2019Class III

ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber...

Name: Z-1876-2019 ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber...
Creator: GE Healthcare, LLC
Published: 2019-05-10
License: https://open.fda.gov/license/

GE Healthcare / initiated 2019-05-10 / Terminated / root cause: manufacturing process

FDA source

GE Healthcare, LLC began a recall of 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... on 2019-05-10. FDA classified it as Class III and gives the reason as "ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1876-2019
Classification: Class III
Status: Terminated
Initiated: 2019-05-10
Posted: 2019-06-26
Terminated: 2024-05-24
Recalling firm: GE Healthcare
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.
Product code: DSA Cable, Transducer And Electrode, Patient, (Including Connector)
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1876-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1875-2019	Class III	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-25
Z-1876-2019	Class III	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-25
Z-1877-2019	Class III	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-25
Z-1878-2019	Class III	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-25
Z-1879-2019	Class III	Terminated	Voluntary: Firm initiated	2019-07-03	2019-06-25

Product code DSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)