GE Healthcare Recalls ECG Leadwire Sets Due to Defibrillation Risk
GE Healthcare is recalling ECG leadwire sets because they may reduce energy reaching patients during defibrillation, potentially limiting treatment success.
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 life-saving defibrillation, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling specific ECG leadwire sets, including 3-lead, 5-lead, and 6-lead configurations with grabber electrodes. The affected products are reusable leadwire sets designed for use with GE equipment requiring rectangular 11-pin ECG trunk cables. The recall covers 58,045 units distributed worldwide, including the United States (nationwide, including Puerto Rico) and numerous international markets.
The recall is 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 injuries, illnesses, or fatalities associated with this defect.
Healthcare facilities and consumers who possess these specific ECG leadwire sets should stop using them for defibrillation procedures. Users should contact GE Healthcare for instructions on how to return the affected units or obtain replacements. The affected catalog numbers and GTIN/UDI codes are listed in the official recall documentation.
The recalled product
- Product
- 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 2
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — ECG Leadwires
- Hazard
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