Generator, Lesion, Radiofrequency

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2023-11-02Open, ClassifiedProcess change control

  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.

• 2023-09-21CompletedProcess change control

  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 altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities.

  Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.

• 2016-11-16TerminatedLabeling Change Control

  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.

• 2016-04-09TerminatedSoftware Manufacturing/Software Deployment

  Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX

  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.

• 2011-01-18TerminatedComponent design/selection

  Stryker Instruments, Interventional Spine RF MultiGen REF 0406-900-000, Rx only,, Stryker Instruments, Kalamazoo, MI (USA), 49001, (269) 323-7700, (800) 253-3210. The product is intended for coagulation of soft tissues in orthopedic, spinal and neuorsurgical applications.

  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

• TerminatedProcess control

  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.

• TerminatedProcess change control

  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.