Recall Z-0257-2020 ยท DQK Computer, Diagnostic, Programmable
GE Healthcare, LLC
CardioLab/ComboLab Recording Systems
| Date | Sep 16, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | GE Healthcare notified customers of the recall on about 09/16/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that certain CLab II Plus Amplifiers used with CardioLab/ComboLab systems have failed 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. Instructions included that customers could continue to use the system by |
| Quantity | 43 (27 US, 16 OUS) |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130626 | MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS Ge Medical Systems Information Technologies, Inc., May 1, 2013 |