NA RFG-4-120VHRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729968337), received between Feb 18, 2022 and Aug 6, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Use of Device Problem

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50151615 ↗
• InjuryFeb 22, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT PATIENT WAS BURNED FROM GROUNDING PAD. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENTS BURN WAS NOT CAUSED BY GENERATOR, BUT IT WAS GROUND PAD CAUSED THE BURN. THE PATIENT JUST HAPPENED TO ALREADY HAVE A SERVICE PLAN IN PLACE FOR THEIR GENERATOR G4-912, SO THEY WANTED TO GET THE GENERATOR CHECKED OUT OR CALIBRATED AS A PRECAUTION.

  Patient problems: Burn(s)

  MAUDE report 16421802 ↗
• MalfunctionFeb 18, 2022Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ELECTRODE HAD A SMELL OF SMOKE LIKE PERHAPS SOMETHING ELECTRICAL IS OVERHEATING INSIDE THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13558462 ↗