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 se
Check against the official notice below — it lists the full affected range.
GE Healthcare, LLC is recalling ECG leadwire sets with multiple catalog numbers (2106389, 2106390, 2106391, 2106393, 2106397, and 2106398 series) in various configurations. Approximately 58,045 units have been distributed worldwide, including 31,108 units in the United States and Puerto Rico, as well as numerous international locations. The products do not have lot or serial codes, so identification is based on catalog and reference numbers.
The ECG trunk cables and leadwires in these sets may reduce the amount of energy reaching a patient during defibrillation, which could limit the success of defibrillating an abnormal patient rhythm. The source document does not specify a remedy for consumers or what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
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. 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, Quantity: 58,045 units (31,108 US; 26937 OUS) in total Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.