Skip to content

HarmonyAIR G-Series Surgical Lighting System (REF LGH36)Recalls & reported problems

Steris Corporation · The G5 Dual Light, High Density Camera Ready, Single Cardanic is used with the HarmonyAIR G-Series Lighting System. · 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 00724995192372), received between Apr 12, 2023 and Apr 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1

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.

  • MalfunctionApr 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE A COVER FROM THEIR SURGICAL LIGHT FELL ONTO THE PATIENT. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AS A PREVENTATIVE ACTION AND THE STERILE FIELD WAS REESTABLISHED SUBSEQUENTLY CAUSING A DELAY; THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16727145 ↗

Other Light, surgical, ceiling mounted devices

All Light, surgical, ceiling mounted devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page