Integrated ECG cable with 3-lead leadwires labeled as the following: 1 — Class III medical device recall Z-1060-2019
Terminated recall by GE Healthcare, LLC, reported 2019-04-03, distributed nationwide. The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the
| Recall number | Z-1060-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-02-22 |
| Classified | 2019-03-26 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, DE, ES, FI, FR, IT, KR, RU, SE |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00840682137829, 00840682137928 |
| Model numbers | 2106309-001, 2106309-002 |
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 enables ECG monitoring with GE monitoring equipment requiring rectangular 11-pin connector cable. These accessories are indicated for use by qualified medical personnel only.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1060-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.