FDA-Device2019-04-03Class III
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.
GE Healthcare, LLC
Hazard
The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient.
Sold states
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.
Affected count
288 devices (23 US, 265 OUS)
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1060-2019Don't want to check this manually?
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