Agency classClass IIIOur severity:Moderate FDA (Devices)·Z-1875-2019·Announced 2019-07-03

GE Healthcare Recalls ECG Trunk Cables Due to Defibrillation Risk

GE Healthcare is recalling ECG trunk cables that may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences. The hazard involves reduced defibrillation efficacy, which is a significant functional defect but falls under the lower severity classification assigned by the agency.

Plain-English summary

GE Healthcare, LLC is recalling specific ECG trunk cables and leadwires. The recall involves 58,045 units distributed worldwide, including the United States and numerous international markets. The affected products include various 3/5-lead, 6-lead, 12-lead, and neonatal ECG trunk cables with AHA, IEC, or DIN connectors.

The recall is being conducted because the cables 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 products do not have lot or serial numbers, but specific REF/Catalog Numbers and GTIN/UDI codes are listed in the recall documentation.

Healthcare facilities and consumers who possess these specific ECG trunk cables should stop using them immediately. Users should contact GE Healthcare for instructions on how to return or replace the affected devices. The recall is classified as Class III by the FDA, indicating that the defect is not likely to cause adverse health consequences.

The recalled product

Product: ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2106305-004 ECG Trunk Cable, 3/5-lead, IEC, 1.2 m/4…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — ECG Cables
Hazard: defibrillation-failure

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

Same manufacturer · GE Healthcare, LLC

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