HarmonyAIR A-Series Lighting System (REF LAH11IN02)Recalls & reported problems
Steris Corporation · The A-Series High Density Single Light, Dual Monitor Mount 51-inch Dual Monitor Mount, 43-inch Light, 20-inch Drop Tube is used with the HarmonyAIR A-Series Lighting System. · Class 2
All models of HarmonyAIR (240)
Data updated Oct 16, 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 00724995187637), received between Oct 21, 2022 and Jul 16, 2025 — classified as 3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Power Problem1
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.
MalfunctionJul 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THEIR DFPM YOKE ASSEMBLY TO THEIR HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM DETACHED FROM THE SPRING ARM AND WAS HANGING FROM THE WIRES WITHIN THE YOKE ASSEMBLY. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22523334 ↗MalfunctionJul 2, 2025Power Problem; Power Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE WALL CONTROL TO THEIR HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM DISPLAYED AN ERROR CODE AND THE LIGHT HEAD WAS FLICKERING RESULTING IN A PROCEDURE DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385984 ↗MalfunctionOct 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THEIR DUAL MONITOR YOKE ASSEMBLY DETACHED FROM THE SUSPENSION ARM OF THEIR HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM AND WAS HANGING BY THE WIRING WITHIN THE LIGHT. THERE WAS NO ONE IN THE ROOM AT THE TIME OF THE REPORTED EVENT. NO REPORT OF INJURY OR PROCEDURAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15651222 ↗
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
- POWERLED TM ARD568474114AMaquet Sas · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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