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GE Healthcare, LLC recalls CardioLab/ComboLab Recording Systems
Recalled November 6, 2019 · FDA recall Z-0257-2020 · GE Healthcare
Hazard
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. · FDA Class II
Units
43 (27 US, 16 OUS)
Sold at
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.
Description
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.
Product
CardioLab/ComboLab Recording Systems
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →