Class II — GE Healthcare, LLC
| Recalling firm | GE HealthCare Technologies Inc. |
|---|---|
| Registered facility | View this company's 50 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| 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. |
| Product | CardioLab/ComboLab Recording Systems |
| 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. |
| Initiated | 2019-09-16 |
| Classified | 2019-10-31 |
| Terminated | 2020-12-16 |
| Recall number | Z-0257-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — GE Healthcare, LLC (Z-0257-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83899/
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