HarmonyAIR A-Series Lighting System (REF LAS02IN01)Recalls & reported problems
Steris Corporation · The A-Series Dual Light with Single Monitor Mount 51-inch Single Monitor Mount, 43-inch Light, 35.5-inch Light, 13-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 00724995187989), received between Nov 16, 2023 and Jul 16, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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
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 ↗
- 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 ↗
Most reported problems
Device problems
- Detachment of Device or Device Component2
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.
MalfunctionJul 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THEIR LIGHT HANDLE ASSEMBLY DETACHED FROM A HARMONYAIR A-SERIES LIGHT HEAD PRIOR TO A PROCEDURE. THE HANDLE ASSEMBLY DID NOT FALL BUT RATHER REMAINED CONNECTED TO AND SUPPORTED BY THE LIGHT HEAD WIRE HARNESS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22523363 ↗MalfunctionNov 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, ONE OF THE LIGHTHEADS FROM THEIR HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM DISCONNECTED FROM THE YOKE ARM. USER FACILITY PERSONNEL WERE ABLE TO SECURE THE LIGHTHEAD AND MOVE IT OUT OF THE WAY. A PROCEDURE DELAY OCCURRED DUE TO THE RE-SETUP; THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18151578 ↗
Other Light, surgical, ceiling mounted devices
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- 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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