Recall Z-1060-2019— GE Healthcare, LLC
Class III · Terminated
Class III FDA medical device recall by GE Healthcare, LLC, initiated 2019-02-22, terminated 2020-08-19. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- GE Healthcare, LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-02-22
- Terminated
- 2020-08-19
- Firm location
- Waukesha, WI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.