HarmonyAIR A-Series Lighting System (REF LAS01IN01)Recalls & reported problems
Steris Corporation · The A-Series Dual Light 43-inch Light, 35.5-inch Light, 13-inch Drop Tube is used with the HarmonyAIR A-Series Lighting System. · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00724995188467), received between Oct 19, 2022 and Jul 10, 2026 — classified as 6 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. How this data works · Data updated Oct 13, 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 · 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 · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Flaked1
- Insufficient Device Problem Information1
- Peeled/Delaminated1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785536 ↗MalfunctionMar 18, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THE LIGHT INTENSITY BUTTON FELL OFF THE HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM DURING A PROCEDURE. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24632240 ↗MalfunctionJan 10, 2025Peeled/Delaminated; Peeled/Delaminated
THE USER FACILITY REPORTED THAT PAINT ON THEIR HARMONYAIR A-SERIES DUAL LIGHT IS CHIPPING AND PEELING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21129522 ↗MalfunctionSep 19, 2024Use of Device Problem; Use of Device Problem
THE USER FACILITY REPORTED THAT PAINT ON MULTIPLE LIGHTHEADS TO THEIR HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEMS ARE CHIPPING AND PEELING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20259922 ↗MalfunctionDec 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THE LIGHT HANDLE OF THEIR HARMONYAIR A-SERIES LIGHTING SYSTEM IS DETACHING AND FALLING DURING USE. NO INJURIES OR PROCEDURE DELAYS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16062815 ↗MalfunctionOct 19, 2022Flaked; Flaked
THE USER FACILITY REPORTED THAT PAINT ON MULTIPLE LIGHTHEADS TO THEIR DUAL HARMONY SURGICAL LIGHTING SYSTEMS IS BUBBLING AND CHIPPING. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15635650 ↗
Other Light, surgical, ceiling mounted devices
- 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
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.