DYONICS ULTRALIGHT 7205971Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010445834), received between Nov 14, 2018 and Nov 14, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical Shorting” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2018Overheating of Device; Positioning Problem

  IT WAS REPORTED THAT THE UNIT WAS NOT ROTATING AND THE HAND PIECE GETS HEATED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8071087 ↗
• MalfunctionNov 14, 2018Electrical Shorting

  IT WAS REPORTED THAT THE DEVICE WAS SHORTING OUT. THERE WAS A BACKUP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY. NO PATIENT INJURIES WERE REPORTED. THIS IS AN OBSOLETE PRODUCT, THEREFORE, THE DEVICE CANNOT BE EXCHANGED, ONLY RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8070166 ↗