GE Healthcare recalls ECG leadwire sets that may reduce defibrillation energy reaching patients, potentially limiting successful heart rhythm treatment. Affected models include 2106389-001 to 2106398-002.
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
GE Healthcare is recalling ECG leadwire sets that could reduce the energy delivered during defibrillation, making it harder to successfully treat heart rhythms. This is serious because defibrillation is critical for life-threatening heart conditions.
The ECG trunk cables and leadwires in these sets may not deliver enough electrical energy to the patient during defibrillation. This could limit the success of treating life-threatening heart rhythms, such as ventricular fibrillation.
Healthcare professionals using these ECG leadwire sets for patient monitoring. Patients receiving defibrillation treatments with these sets are at risk of treatment failure.
Check for ECG leadwire sets with REF/Catalog numbers 2106389-001 through 2106398-002. These sets have specific lengths and configurations (5-lead, 3-lead, or 6-lead) and are used with GE equipment requiring rectangular 11-pin ECG trunk cables.
Look for REF/Catalog numbers 2106389-001 to 2106398-002 on the leadwire set packaging or label.
Reach out to GE Healthcare for specific guidance on whether your leadwire set is affected and what to do next.
The ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patient's rhythm.
Check for REF/Catalog numbers 2106389-001 through 2106398-002. These sets have specific lengths and configurations (5-lead, 3-lead, or 6-lead) and are used with GE equipment requiring rectangular 11-pin ECG trunk cables.
The recall does not require immediate discontinuation; healthcare professionals should check if their leadwire sets are affected and contact GE Healthcare for guidance.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1876-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1876-2019 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
