FDA Device recall Z-0257-2020
CardioLab/ComboLab Recording Systems
- FDA Device
- Class II
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of CardioLab/ComboLab Recording Systems by Ge Healthcare, citing 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, the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0257-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-16 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
CardioLab/ComboLab Recording Systems
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.
Identifiers
| code_info | Model Number: 2088700-002, No UDI Number, Lot Numbers: RXJ19122006TA, RXJ19122002TA, RXJ19122010TA, RXJ19122001TA, RXJ…Model Number: 2088700-002, No UDI Number, Lot Numbers: RXJ19122006TA, RXJ19122002TA, RXJ19122010TA, RXJ19122001TA, RXJ19122005TA, RXJ19122007TA; Model Number: 2088700-004, UDI Number (Lot Numbers): 01008406821196031119050021RXJ19204004TA (RXJ19204004TA), 01008406821196031119040021RXJ19154006TA (RXJ19154006TA), 01008406821196031119050021RXJ19224011TA (RXJ19224011TA), 01008406821196031119050021RXJ19224017TA (RXJ19224017TA), 01008406821196031119050021RXJ19224014TA (RXJ19224014TA), 01008406821196031119040021RXJ19154009TA (RXJ19154009TA), 01008406821196031119040021RXJ19154011TA (RXJ19154011TA), 01008406821196031119040021RXJ19154010TA (RXJ19154010TA), 01008406821196031119040021RXJ19154007TA (RXJ19154007TA), 01008406821196031119050021RXJ19194009TA (RXJ19194009TA), 01008406821196031119040021RXJ19154003TA (RXJ19154003TA), Not Available (RXJ19224002TA), 01008406821196031119050021RXJ19224016TA (RXJ19224016TA), 01008406821196031119050021RXJ19204003TA (RXJ19204003TA), 01008406821196031119040 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0257-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.