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HarmonyAIR A-Series Camera (REF LAH0026)Recalls & reported problems

Steris Corporation · The High Density Light Handle Camera Module is used with the HarmonyAIR A-Series Lighting System. · Class 1

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 00724995182427), received between Jul 20, 2023 and Jul 20, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Power 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Power 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.

  • MalfunctionJul 20, 2023Power Problem; Power Problem

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE IN-LIGHT CAMERA TO ONE OF THE LIGHTHEADS ON THEIR HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM WAS NOT OPERATING PROPERLY. A SECTION OF THE LIGHTHEAD WAS ALSO NOT ILLUMINATING. USER FACILITY PERSONNEL UTILIZED THE OTHER LIGHTHEADS AND COMPLETED THE PATIENT PROCEDURE. A PROCEDURE DELAY OCCURRED DUE TO THE REPORTED EVENT. NO REPORT OF INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17362617 ↗

Other CAMERA, SURGICAL AND ACCESSORIES devices

All CAMERA, SURGICAL AND ACCESSORIES devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.