GE Healthcare Recalls ECG Leadwire Sets Due to Defibrillation Risk
GE Healthcare is recalling specific ECG leadwire sets because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could limit the success of defibrillation, a life-saving procedure. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and the agency classification is Class III.
Plain-English summary
GE Healthcare, LLC is recalling specific ECG leadwire sets with snap ends. The recall involves 58,045 units distributed worldwide, including the United States and numerous international markets. The affected products are reusable leadwire sets designed for use with GE equipment requiring rectangular 11-pin ECG trunk cables.
The recall is being issued because the ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation. This reduction in energy delivery could potentially limit the success of defibrillating the patient's rhythm. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and consumers should identify the affected units by checking the REF/Catalog Numbers and GTIN/UDI codes listed in the official recall documentation. Affected catalog numbers include 2106381-001 through 2106396-002. Users should stop using these specific leadwire sets for defibrillation procedures and contact GE Healthcare for further instructions or replacement.
The recalled product
- Product
- Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in 2106381-004 ECG Leadwire se
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — ECG Leadwires
Distribution
Part of a larger recall action
This product is one of 5 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · GE Healthcare, LLC
See all →- HighGE SIGNA Premier MRI magnets may have ferrous fittings fitted
FDA (Devices) · 2026-04-08
- HighGE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
FDA (Devices) · 2022-08-31
- HighGE Healthcare CT, PET, and NM Patient Tables May Drop During Service
FDA (Devices) · 2022-08-17
- HighGE Centricity PACS Software fails to notify of exam study modifications
FDA (Devices) · 2022-08-03
- HighSIGNA Premier MRI scanner recalled for elevated acoustic noise hazard
FDA (Devices) · 2022-07-27
Same hazard · defibrillation failure
See all →- HighZOLL Powerheart G5 AED shipping film may prevent shock delivery
FDA (Devices) · 2024-07-17
- SevereEar oximeter sensor recalled for defibrillation and voltage safety concerns
FDA (Devices) · 2023-07-12
- SevereFDA Recalls TruSignal AllFit Oximeter Sensors Worldwide for Device Malfunction
FDA (Devices) · 2023-07-12
- SevereTruSignal Wrap Sensor Oximeter Recalled for Defibrillation Failure
FDA (Devices) · 2023-07-12
- SevereGE TruSignal Ear Sensor oximeter recalled for electrical and measurement hazards
FDA (Devices) · 2023-07-12