Recall Z-0209-2024 ยท GXD Generator, Lesion, Radiofrequency
Abbott
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
| Date | Nov 2, 2023 (initiated Sep 28, 2023) |
| Status | Open, Classified |
| Reason | Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure. |
| Root cause | Process change control |
| Action | Abbott issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 09/28/2023 via FedEx 2nd day delivery. The notice explained the problem, risk, and requested return of the device for inspection. Those devices which pass, will be returned. Should your device(s) fail the inspection, your local Abbott Representative can advise the consignee of alternate commercially available products. |
| Quantity | 34 devices |
| Distribution | US, Taiwan, and Colombia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111576 | NT 2000 LESIONING GENERATOR Neuro Therm, Inc., Sep 20, 2011 |