Recall Z-1879-2019— GE Healthcare, LLC
Class III · Terminated
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 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.. 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
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.