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Recall Observatory FDA recall evidence

Device 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.

Z-1060-2019

February 22, 2019

Class III

Product summary

Firm
GE Healthcare, LLC
Event
Event 82272
Status
Terminated
Classification
Class III
Quantity
288 devices (23 US, 265 OUS)
Official record key
device-enforcement:Z-1060-2019

Official wording

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.

Code information: 1. Catalog Number 2106309-001, GTIN 00840682137928; 2. Catalog Number 2106309-002, GTIN 00840682137829

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Integrated ECG cable with 3-lead leadwires can short circuit during defibrillation and conduct 25% of the defibrillation energy away from the patient.