HarmonyAIR M-Series Surgical Lighting System (REF LMH02)Recalls & reported problems
Steris Corporation · The M5 High Density Dual Package, Single Flat Panel Monitor Mount, No Hub Spacer is used with the HarmonyAIR M-Series Lighting System. · Class 2
All models of HarmonyAIR (240)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995191566), received between Jun 15, 2023 and Feb 21, 2025 — classified as 3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED A PIECE TO THE SURGICAL LIGHTHEAD COVER TO THEIR HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM FELL OFF DURING PROCEDURE. THE USER FACILITY QUICKLY REESTABLISHED THE STERILE FIELD BY COVERING THE BROKEN PIECE WITH A STERILE TOWEL AND PROCEEDING WITH THE PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY; NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21433392 ↗MalfunctionApr 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THE SURGICAL LIGHTHEAD COVER TO A HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM FELL OFF DURING PROCEDURE. THERE WAS A PROCEDURE DELAY AS THE FACILITY PERSONNEL HAD TO REESTABLISH THE STERILE FIELD. PROCEDURE WAS COMPLETED AND NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19055278 ↗MalfunctionJun 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE CONNECT POINT OF THEIR HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM BECAME LOOSE, DRIFTING DOWN STRIKING THE ANESTHESIOLOGIST ON THE HEAD. THERE WERE NO REPORTS OF INJURY NOR ANY PROCEDURAL DELAYS/CANCELLATIONS INVOLVING THIS EVENT. THE INTENDED PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17137823 ↗
Other Light, surgical, ceiling mounted devices
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls6 reports
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls2 reports
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls2 reports
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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