CardioLab/ComboLab Recording Systems — Class II medical device recall Z-0257-2020
Terminated recall by GE Healthcare, LLC, reported 2019-11-06, distributed nationwide. Potential for failure of the patient leakage current test. There is a potential that if another device with el
| Recall number | Z-0257-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-09-16 |
| Classified | 2019-10-31 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2020-12-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, ES, FR, IN, JP, KR, MX, TW |
| Reason classes | packaging |
| Lot numbers | RXJ19122001TA, RXJ19122002TA, RXJ19122005TA, RXJ19122006TA, RXJ19122007TA, RXJ19122010TA |
| Model numbers | 2088700-002, 2088700-004 |
Product
CardioLab/ComboLab Recording Systems
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 Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0257-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.