Handpiece Harmony/Aria (E) 540 VL/PL 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17290110120433), received between Dec 11, 2018 and Dec 11, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE SUSPECTED DEVICE WAS USED ON PATIENT'S LEGS BILATERALLY FOR BENIGN PIGMENTED LESIONS. THE FACILITY PROVIDED THE PATIENT WITH BIAFINE TOPICAL EMULSION AND 800 MG IBUPROFEN AS POST-TREATMENT CARE. PER THE FACILITY, THE PATIENT WAS SEEING A WOUND CARE SPECIALIST AS AN OUT-PATIENT INITIALLY BUT WAS LATER ADMITTED AS AN IN-PATIENT.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 8152571 ↗