Generator, Lesion, Radiofrequency
Neurology · 21 CFR 882.4400
Recent MDR events
1,812 adverse event reports on file
- IonicRF¿ GeneratorJul 27, 2026MalfunctionAbbott Medical (af-st. Paul)2184149-2026-00207
- IONICRF¿ GENERATORJul 15, 2026InjuryAbbott Medical (af-st. Paul)2184149-2026-00198
- IONICRF¿ GENERATORJul 15, 2026InjuryAbbott Medical (af-st. Paul)2184149-2026-00200
- MULTIGEN 2Jul 9, 2026MalfunctionStryker Corp25762039
- IONICRF¿ GENERATORJul 1, 2026InjuryAbbott Medical (af-st. Paul)2184149-2026-00190
- COSMAN RFG-4Jun 29, 2026InjuryBoston Scientific Neuromodulation Corporation3006630150-2026-04465
- IONICRF¿ GENERATORJun 24, 2026InjuryAbbott Medical (af-st. Paul)2184149-2026-00183
- IONICRF¿ GENERATORJun 22, 2026InjuryAbbott Medical (afd-plymouth)3005334138-2026-00320
- IONICRF¿ GENERATORJun 15, 2026DeathAbbott Medical (af-st. Paul)2184149-2026-00164
- IONICRF¿ GENERATORJun 11, 2026InjuryAbbott Medical (af-st. Paul)2184149-2026-00175
Event type breakdown
Recalls
7 recall events for this product code
- AbbottOpen, ClassifiedNov 2, 2023
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
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.
Z-0209-2024 · View FDA record ↗ - Avanos Medical, Inc.CompletedSep 21, 2023
COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or al
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
Z-2622-2023 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedNov 16, 2016
RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U
Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen cables.
Z-0584-2017 · View FDA record ↗ - Neurotherm, Inc.TerminatedApr 9, 2016
Neurotherm NT2000iX RF Generator
NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes were not cleared in the United States for use.
Z-1361-2016 · View FDA record ↗ - Stryker Instruments Div. of Stryker CorporationTerminatedJan 18, 2011
Stryker Instruments, Interventional Spine RF MultiGen REF 0406-900-000, Rx only,, Stryker Instruments, Kalamazoo, MI (USA), 49001, (269) 323-7700, (800) 253-321
This recall is related to the Electri-cord recall. There is a risk when excessive force is applied to the plugs, a fracture can develop on the prongs inside the molded section of the plug. Over time the fracture may lead to arcing inside of the molded section of the plug and a build up of heat which can cause charring, electric shock or fire. To this date there have been zero complaint for this
Z-0915-2011 · View FDA record ↗ - Abbott MedicalTerminatedUnknown
Radiofrequency Grounding Pad, REF RF-DGP-L
Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating.
Z-0664-2020 · View FDA record ↗ - Abbott Laboratories Inc. (St Jude Medical)TerminatedUnknown
NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-NT-2000
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.
Z-1549-2021 · View FDA record ↗
Registered firms
88 firms currently registered for this product code
Avanos Medical, Inc.
Alpharetta, GA, US
Safemed Medical Devices S.r.o.
Prague Praha, Hlavni Mesto, CZ
Isomedix Operations, Inc.
Temecula, CA, US
Stellartech Research Corp.
Milpitas, CA, US
Pajunk Gmbh Medizintechnologie
GEISINGEN Baden-Wurttemberg, DE
Nortech Systems, Inc.
Milaca, MN, US
Armor Plast Ltd
Bangalore Karnataka, IN
Rbc Development Llc Dba Rbc Medical Innovations Dba Vantage Medtech
Lenexa, KS, US
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Midwest Sterilization Corp.
JACKSON, MO, US
Diros Technology, Inc.
MARKHAM Ontario, CA
St. Jude Medical, Cardiology Division, Inc.
Plymouth, MN, US
Boston Scientific Limited
CLONMEL Tipperary, IE
Abbott Medical
PLANO, TX, US
St. Jude Medical, Atrial Fibrillation Division, Inc.
Saint Paul, MN, US
Boston Scientific Neuromodulation Corporation
Valencia, CA, US
Boston Scientific Corporation
Saint Paul, MN, US
Schneider Asr B.v.
Rotterdam-Albrandswaard Zuid-Holland, NL
Quality Tech Services, Llc
Bloomington, MN, US
Epimed International, Inc.
JOHNSTOWN, NY, US
510(k) clearances
37 clearances for this product code
- Boston Scientific Neuromodulation CorporationAug 7, 2025
K251247 · GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
- Avanos Medical, Inc.Aug 14, 2024
K242057 · COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
- Epimed InternationalMay 24, 2024
K232632 · Racz Neurostat RF Generator
- Neuroone Medical Technologies Corp.Dec 6, 2023
K231675 · OneRF Ablation System
- Rf Innovations, Inc.Mar 15, 2023
K220122 · APEX 6
- ABBOTT MEDICALJan 21, 2022
K203293 · Abbott Medical Grounding Pad, model RF-DGP-IS
- ABBOTT MEDICALOct 21, 2020
K201610 · IonicRF Generator
- Avanos Medical, Inc.Feb 21, 2020
K192491 · Coolief Radiofrequency Generator (CRG) System