GE Healthcare recalls 5-lead and 3-lead ECG leadwire sets with snap ends that may reduce defibrillation energy delivery, risking failed heart rhythm treatment during emergencies.
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 with snap ends that could reduce the energy delivered during defibrillation, potentially making it harder to treat life-threatening heart rhythms. This affects medical devices used in hospitals and clinics for heart monitoring.
These leadwires may not conduct electrical energy properly during defibrillation, reducing the amount of energy that reaches the patient's heart. This could lead to failed defibrillation attempts when treating life-threatening heart rhythms, such as ventricular fibrillation.
Healthcare providers using GE Healthcare ECG leadwire sets with snap ends for patient monitoring. Patients undergoing defibrillation procedures are at risk if the leadwires fail to deliver adequate energy.
Check for the following REF/Catalog numbers: 2106381-001 to 2106396-002. The sets have snap ends and are labeled as ECG leadwire sets with specific lead counts (5-lead, 3-lead) and lengths (74 cm/29 in or 130 cm/51 in).
Look for the REF/Catalog numbers listed in the recall notice to confirm if your ECG leadwire set is affected.
Reach out to GE Healthcare for guidance on next steps if you have the recalled leadwire sets.
The leadwires may reduce the energy delivered during defibrillation, potentially making it harder to treat life-threatening heart rhythms.
Check for the REF/Catalog numbers 2106381-001 to 2106396-002 on the product label or packaging.
The recall does not require immediate discontinuation; healthcare providers should contact GE Healthcare for specific 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-1878-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1878-2019 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.