Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT; 2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT Product Usage: The reusable ECG trunk cable enables ECG monitoring with GE monit
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled Integrated ECG cables with 3-lead leadwires (Catalog Numbers 2106309-001 and 2106309-002) distributed worldwide and across multiple U.S. states. The cables can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient rather than to the patient. A total of 288 devices were affected (23 in the U.S. and 265 outside the U.S.).
The recall source does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient.
Reason for recall: The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient. Distribution: Worldwide Distribution - US Nationwide to AK, KS, MA, MA, ME, NJ, NJ, NM, NY, TX. Distributed worldwide to Chile, Finland, France, Germany, Italy, Korea (Republic Of), Russia, Spain, Sweden. Quantity: 288 devices (23 US, 265 OUS) Lot/code info: 1. Catalog Number 2106309-001, GTIN 00840682137928; 2. Catalog Number 2106309-002, GTIN 00840682137829
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.