HarmonyAIR M-Series Surgical Lighting System (REF LM01N)Recalls & reported problems
Steris Corporation · The Dual M5 Air without Control 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995165918), received between May 17, 2023 and Nov 13, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2025Unintended Movement; Unintended Movement
THE USER FACILITY REPORTED THAT DURING SET UP FOR A PATIENT PROCEDURE, AN EMPLOYEE WAS MOVING THE LIGHTHEAD TO THEIR HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM AND THE LIGHTHEAD "FELL". THE PATIENT WAS TRANSFERRED TO ANOTHER ROOM, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544744 ↗MalfunctionMay 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE AN END COVER DETACHED FROM THEIR HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM AND FELL INTO THE STERILE FIELD. A PROCEDURE DELAY OCCURRED AS THE STERILE FIELD WAS RE-ESTABLISHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16947897 ↗
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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