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HarmonyAIR E-Series (REF LES11IN01)Recalls & reported problems

Steris Corporation · The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads. · Class 2

All models of HarmonyAIR (240)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00724995175542), received between Nov 10, 2022 and Nov 10, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Problem” (1 report).

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 18, 2026.

Most reported problems

Device problems

  • Separation Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 10, 2022Separation Problem; Separation Problem

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE ONE OF THE DUAL MONITOR YOKES TO THEIR HARMONYAIR E-SERIES SURGICAL LIGHTING SYSTEM SEPARATED FROM THE SPRING ARM AND WAS HANGING BY THE LIGHTING SYSTEM CABLES. USER FACILITY PERSONNEL STABILIZED THE MONITORS ON A STAND RESULTING IN A PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15771929 ↗

Other Light, surgical, ceiling mounted devices

All Light, surgical, ceiling mounted devices →

Sources and updates

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