NeuroTherm NT2000iX Radiofrequency — Class II medical device recall Z-1549-2021
Terminated recall by Abbott Laboratories Inc. (St Jude Medical), reported 2021-05-19. Potential capacitor failure which typically manifests as in inability to provide output on one or more channel
| Recall number | Z-1549-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Laboratories Inc. (St Jude Medical), Saint Paul, MN, United States |
| Recall initiated | 2021-04-22 |
| Classified | 2021-05-10 |
| Reported by FDA | 2021-05-19 |
| Terminated | 2023-02-02 |
| Countries outside the US | AU, BE, CO, CR, EG, GB, IL, KR, SG, TW, ZA |
| Quantity | 318 units |
| UPC / GTIN / UDI-DI | 05415067022417 |
| Serial numbers | 17856737, 17856738, 17856739, 17860513, 17860514, 17860515, 17863602, 17865145, 17903459, 17905956, 17905959, 17905962, 17905963, 17905965, 17942355, 17959675, 17959676, 17959677, 17964784, 17981233, 17981234, 17981235, 17981236, 17991994, 17991997 and 224 more |
| Model numbers | RFG-NT-2000 |
Product
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
Reason for recall
Potential capacitor failure which typically manifests as in inability to provide output on one or more channels. In some instances, users reported a charring/smoky odor or emission.
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-1549-2021. 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.