Recall Z-1877-2019— GE Healthcare, LLC

Class III FDA medical device recall by GE Healthcare, LLC, initiated 2019-05-10, terminated 2024-05-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 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.. 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..

Recalling firm

GE Healthcare, LLC

Classification

Class III

Status

Terminated

Initiated

2019-05-10

Terminated

2024-05-24

Firm location

Waukesha, WI, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.