HarmonyAIR G-Series Lighting SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00724995207595), received between Jun 15, 2023 and Oct 23, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, A JOINT COVER FROM THEIR HARMONYAIR G-SERIES SURGICAL LIGHTING SYSTEM DETACHED AND CONTACTED THE PATIENT. THE COVER WAS IMMEDIATELY REMOVED FROM THE STERILE FIELD, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369230 ↗
• MalfunctionSep 17, 2024Break; Break

  THE USER FACILITY REPORTED DURING A PATIENT PROCEDURE THAT A PIECE OF PLASTIC DETACHED FROM THEIR HARMONYAIR G-SERIES DUAL LIGHT AND FELL ONTO THE STERILE FIELD. NO REPORT OF INJURY OR PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20238684 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED HALF OF THE YOKE COVER TO THEIR HARMONYAIR G-SERIES LIGHTING SYSTEM DETACHED AND FELL DURING A PATIENT PROCEDURE. THE YOKE COVER FELL INTO THE STERILE FIELD. THE AFFECTED INSTRUMENTS WERE REPLACED, THERE WAS NO IMPACT TO THE PATIENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT REPORT OF DELAY. THE LIGHTING SYSTEM WAS REMOVED FROM SERVICE AWAITING ONSITE INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19941621 ↗
• MalfunctionJun 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT DURING A PROCEDURE THE PLASTIC COVER DETACHED FROM THEIR HARMONYAIR G-SERIES SURGICAL LIGHTING SYSTEM AND CONTACTED THE PATIENT. THE STERILE FIELD WAS REESTABLISHED RESULTING IN A PROCEDURE DELAY, AND THE SCHEDULED PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134686 ↗