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HarmonyAIR E-Series (REF LEH02INNDT)Recalls & reported problems

Steris Corporation · The HarmonyAIR E-Series High Definition Dual Light with Single Flat Panel Monitor, No 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
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 00724995172749), received between Mar 24, 2022 and Mar 24, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Device problems

  • Device Dislodged or Dislocated1

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.

  • MalfunctionMar 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    THE USER FACILITY REPORTED THAT ONE OF THE LIGHTHEADS DETACHED FROM THE SPRING ARM OF THEIR HARMONYAIR E-SERIES SURGICAL LIGHTING SYSTEM. NO REPORT OF INJURY OR PROCEDURE DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13895676 ↗

Other Light, surgical, ceiling mounted devices

All Light, surgical, ceiling mounted devices →

Sources and updates

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