GE Healthcare, LLC recalls CardioLab/ComboLab Recording Systems

Recall date

September 16, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0257-2020

FDA classification

Class II

Brand / firm

GE Healthcare, LLC

Sold / distributed

Nationwide distribution to CA, CT, FL, IN, MD, MI , MN, MO, NC, NE, NJ, OH, PA, TX, WI. International distribution to Canada, France, India, Japan, Korea (Republic Of), Mexico, Spain, Taiwan.

Why it was recalled

Potential for failure of the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab II Plus Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CardioLab/ComboLab Recording Systems