The Recall Desk
HighFDA (Devices)·Z-1060-2019·Announced 2019-04-03

GE Healthcare Recalls Integrated ECG Cables Due to Short Circuit Risk

GE Healthcare is recalling 288 integrated ECG cables that can short circuit during defibrillation, potentially diverting 25% of the energy away from the patient.

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 high-risk medical device defect that can compromise life-saving defibrillation, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare, LLC is recalling 288 units of Integrated ECG cables with 3-lead leadwires. The affected products are identified by Catalog Number 2106309-001 (GTIN 00840682137928) and Catalog Number 2106309-002 (GTIN 00840682137829). These reusable cables are indicated for use by qualified medical personnel with GE monitoring equipment requiring rectangular 11-pin connectors.

The recall is due to a defect where the cables can short circuit during defibrillation. This malfunction can conduct 25% of the defibrillation energy away from the patient, which may compromise the effectiveness of the life-saving procedure.

The devices were distributed worldwide, including to specific US states (AK, KS, MA, ME, NJ, NM, NY, TX) and countries such as Chile, Finland, France, Germany, Italy, Korea, Russia, Spain, and Sweden. A total of 23 units were distributed in the US and 265 units were distributed outside the US. No injuries or illnesses have been reported in the source text.

The recalled product

Product
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
Manufacturer
GE Healthcare, LLC
Category
Medical Device — ECG Cables
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 1. Catalog Number 2106309-001
  • GTIN 00840682137928
  • 2. Catalog Number 2106309-002
  • GTIN 00840682137829

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Related recalls

Same manufacturer · GE Healthcare, LLC

See all →

Same hazard · short circuit

See all →