Recall Z-1060-2019 ยท IKD Cable, Electrode
GE Healthcare, LLC
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
| Date | Feb 22, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Consignees were initially notified via telephone call on about 02/22/2019 and followed up with an "URGENT MEDICAL DEVICE CORECTION" letter. Instructions included to immediately stop use of the affected Integrated ECG cables and quarantine any on hand. GE Healthcare will replace all affected cables at no cost and a GE Healthcare representative will contact each customer to arrange for the collection of the affected cables and provide replacement of new cables. Questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171. |
| Quantity | 288 devices (23 US, 265 OUS) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.