Recall Z-1549-2021 ยท GXD Generator, Lesion, Radiofrequency
Abbott Laboratories Inc. (St Jude Medical)
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
| Date | Apr 22, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process change control |
| Action | The firm issued a medical device correction/service notice beginning on 04/22/2021. The notice discusses device failure and how to identify it. Should the failure present, then firm is requesting return of the device for servicing. |
| Quantity | 318 units |
| Distribution | US and AUSTRALIA, EGYPT, SOUTH AFRICA, BELGIUM, COLOMBIA, UNITED KINGDOM, COSTA RICA, ISRAEL, SOUTH KOREA, SINGAPORE, TAIWAN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111576 | NT 2000 LESIONING GENERATOR Neuro Therm, Inc., Sep 20, 2011 |