GE Healthcare, LLC: Medical Device Recall in 2019 - (Recall #: Z-1879-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 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 Classification:

Class III

Date Initiated: May 10, 2019

Date Posted: July 3, 2019

Recall Number: Z-1879-2019

Event ID: 82937

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.

Status: Terminated

Product Quantity: 58,045 units (31,108 US; 26937 OUS) in total

Code Information:

product does not have lot or serial codes no GTIN/UDI

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated