Z-0209-2024Class II

Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator

Name: Z-0209-2024 Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Creator: Abbott
Published: 2023-09-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-09-28 / Open, Classified

FDA source

Abbott began a recall of Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator on 2023-09-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0209-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-28
Posted: 2023-11-02
Recalling firm: Abbott Medical
Product: Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Product code: GXD Generator, Lesion, Radiofrequency
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.
FDA 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 in commerce: 34 devices
Distribution: US, Taiwan, and Colombia
Product codes and lots: UDI/DI 05415067022417, serial numbers: 16930509, 16983330, 17583407, 17634837, 17783928, 17783930, 17905961, 17928413, 17954521, 17991999, 18047384, 18493711, 18522937, 18675068, 18690920, 18709734, 18742997, 2475-12, 2504-12, 2547-13, 2885-14, 3003-14, 3278-15, 3450-15, 3550-15, 17942357, 18003310, 18102335, 18132017, 18132092, 18657521, 18666647, 19182119, 19197174

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0209-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0209-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-08	2023-11-02

Product code GXD

K111576Class IINt 2000 Lesioning GeneratorNeuro Therm, Inc. / cleared 2011-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)