Z-1060-2019 Class III Terminated
FDA device recall Z-1060-2019 was initiated by GE Healthcare, LLC on February 22, 2019 and is designated Class III. 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. The recall status is terminated (terminated August 19, 2020). Affected quantity: 288 devices (23 US, 265 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2019
- Initiation Date
- February 22, 2019
- Termination Date
- August 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 288 devices (23 US, 265 OUS)
Product Description
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.
Distribution Pattern
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.
Code Information
1. Catalog Number 2106309-001, GTIN 00840682137928; 2. Catalog Number 2106309-002, GTIN 00840682137829