HarmonyAIR M-Series Surgical Lighting System (REF LMH01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995191542), received between Nov 4, 2022 and Apr 27, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 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.

• MalfunctionApr 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE COVER TO THEIR HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM DETACHED DURING A PROCEDURE, ENTERING THE STERILE FIELD. A PROCEDURE DELAY OCCURRED AS THE STERILE FIELD WAS RE-ESTABLISHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822725 ↗
• MalfunctionNov 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT A LIGHTHEAD DETACHED AND HAD FALLEN FROM THEIR HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM. THERE WAS NO PATIENT IN THE ROOM AT THE TIME OF THE REPORTED EVENT. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15737093 ↗