FDA Device recall Z-1060-2019
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/1…
- FDA Device
- Class III
- terminated
- Published 2019-04-03
On 2019-04-03 the FDA classified a Class III recall of 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/1… by Ge Healthcare, citing the Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1060-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-02-22 |
| Published | 2019-04-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
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
The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient.
Identifiers
| code_info | 1. Catalog Number 2106309-001, GTIN 00840682137928; 2. Catalog Number 2106309-002, GTIN 00840682137829 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1060-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.