# FDA recall Z-1878-2019

> **GE Healthcare, LLC** · Class III · device recall initiated 2019-05-10.

## Product

Leadwire sets with snap ends:  REF/Catalog Number	Description  2106381-001	ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in  2106381-002	ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in  2106381-003	ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in  2106381-004	ECG Leadwire set, 5-lead, snap, IEC, 130 cm/ 51 in  2106381-005	ECG Leadwire set, 5-lead, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in  2106383-001	ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 cm/ 29 in  2106383-002	ECG Leadwire set, 5-lead, grouped, snap, AHA, 130 cm/ 51 in  2106383-003	ECG Leadwire set, 5-lead, grouped, snap, IEC, 74 cm/ 29 in  2106383-004	ECG Leadwire set, 5-lead, grouped, snap, IEC, 130 cm/ 51 in  2106383-005	ECG Leadwire set, 5-lead, grouped, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in  2106383-006	ECG Leadwire set, 5-lead, grouped, snap, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in  2106385-001	ECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 in  2106385-002	ECG LEADWIRE SET, 3-LD GROUPED, SNAP, AHA, 130 CM/ 51 

## Reason for recall

ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.

## Distribution

Worldwide Distribution: US (nationwide)  including Puerto Rico, and countries of: Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malta, Mauritius, Mexico, Moldova, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Palestine (state of), Panama, Poland, Qatar, Republic of Serbia, Romania, Russia, Saudia Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Ur

## Key facts

- **Recall number:** Z-1878-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-10
- **Report date:** 2019-07-03
- **Termination date:** 2024-05-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1878-2019

## Citation

> AI Analytics. FDA recall Z-1878-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1878-2019. Source: US FDA. Licensed CC0.

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