HarmonyAIR A-Series Lighting System (REF LAH02IN02)Recalls & reported problems
Steris Corporation · The A-Series Dual High Density Light with Single Monitor Mount 51-inch Single Monitor Mount, 43-inch Light, 35.5-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
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995186074), received between Jan 15, 2025 and Aug 8, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
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
Recalls naming this device
- May 15, 2026Open, Classified
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Z-2448-2026 · Root cause: Process change control · Recall details · FDA record ↗
- May 15, 2026Open, Classified
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Z-2449-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Intermittent Loss of Power1
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.
MalfunctionAug 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE LIGHTHEAD OF THEIR HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM DETACHED FROM THE YOKE ASSEMBLY. THE LIGHTHEAD DID NOT FALL BUT REMAINED CONNECTED TO AND SUPPORTED BY THE WIRES WITHIN THE ASSEMBLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22750730 ↗MalfunctionJan 15, 2025Intermittent Loss of Power; Intermittent Loss of Power
THE USER FACILITY REPORTED DURING A PATIENT PROCEDURE THEIR HARMONY AIR A-SERIES SURGICAL LIGHTING SYSTEM EXPERIENCED A LOSS OF CONTROL OF THE LIGHTS AND HAD TO RESTART THE SYSTEM AT THE WALL CONTROL RESULTING IN A SHORT PROCEDURE DELAY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21160925 ↗
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
- 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
- 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 · each recall links to the FDA recall notice
- 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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