Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
FDA Recall Z-0209-2024 · Posted 2023-11-02
Recalling FirmAbbott
Recall StatusOpen, Classified
Product CodeGXD
Date Initiated2023-09-28
Product Quantity34 devices
Reason for Recall
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.
Firm 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.
Root Cause
Process change control
Distribution Pattern
US, Taiwan, and Colombia
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.