FDA-Device2019-11-06Class II
CardioLab/ComboLab Recording Systems
GE Healthcare, LLC
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.
Sold states
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.
Affected count
43 (27 US, 16 OUS)
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
CardioLab/ComboLab Recording Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0257-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief