HarmonyAIR E-Series (REF LES01IN01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995173746), received between Apr 15, 2022 and Jul 25, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJul 25, 2024Device Handling Problem; Device Handling Problem

  THE USER FACILITY REPORTED THAT A PAINT CHIP FROM THEIR LIGHT SPINDLE FELL INTO THE STERILE FIELD DURING A PATIENT PROCEDURE. THE LIGHT SPINDLE IS ATTACHED TO THE HARMONY AIR E-SERIES LIGHTING SYSTEM. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828043 ↗
• MalfunctionJul 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  HOLD R. P 10.31.2022 THE USER FACILITY REPORTED THAT THEIR HARMONYAIR E-SERIES SURGICAL LIGHTHEAD FELL. THERE WAS NO ONE IN THE ROOM AT THE TIME OF THE REPORTED EVENT. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14956409 ↗
• MalfunctionApr 15, 2022Device Handling Problem; Device Handling Problem

  THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES, THE TOUCHSCREEN TO THEIR HARMONY AIR SURGICAL LIGHTING SYSTEM E SERIES WAS NOT WORKING PROPERLY. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119068 ↗