Drug recall
CardioLab/ComboLab Recording Systems
FDA recall event 83899 · Class II · GE Healthcare, LLC
Key facts
| Event ID | 83899 |
|---|---|
| Recall numbers | Z-0257-2020 |
| Recalling firm | GE Healthcare, LLC |
| Product type | Devices |
| Products | CardioLab/ComboLab Recording Systems |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Sep 16, 2019 |
| Report date | Nov 6, 2019 |
| Termination date | Dec 16, 2020 |
| City | Waukesha |
| State | WI |
| Country | United States |
| FEI number | 2126677 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: