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HarmonyAIR A-Series Lighting System (REF LAS12IN01T)Recalls & reported problems

Steris Corporation · The A-Series Single Light 43-inch Light, 13-inch Drop Tube, Tandem 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
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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.

Recalls naming this device

  1. 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 ↗

  2. 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 ↗

Other Light, surgical, ceiling mounted devices

All Light, surgical, ceiling mounted devices →

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