HarmonyAIR E-Series (REF LEH02IN02T)Recalls & reported problems
Steris Corporation · The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, 20-inch Drop Tube, Tandem is a ceiling supported surgical lighting system of one or more E-Series lightheads. · Class 2
All models of HarmonyAIR (240)
Data updated Oct 16, 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 00724995172732), received between Nov 7, 2024 and Dec 31, 2024 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Break1
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.
MalfunctionDec 31, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE USER FACILITY REPORTED AT THE END OF A PATIENT PROCEDURE WHILE REPOSITIONING THEIR DUAL YOKE ASSEMBLY IT DETACHED FROM THE SPRING ARM. NO REPORT OF INJURY OR PROCEDURE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21046964 ↗MalfunctionNov 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE YOKE ASSEMBLY OF THEIR HARMONY AIR E-SERIES SURGICAL LIGHTING SYSTEM DETACHED FROM THE SPRING ARM AND WAS HANGING BY THE CABLES RESULTING IN A SHORT PROCEDURE DELAY. THE YOKE ASSEMBLY WAS RESECURED TO THE SPRING ARM BY USER FACILITY PERSONNEL, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20632084 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page