HarmonyAIR A-Series Lighting System (REF LAH24NCNDA)Recalls & reported problems

Steris Corporation · The A-Series High Definition Single Light 43-inch, Single Flat Panel Monitor, No Drop Tube, Non-Camera Adjustable is used with the HarmonyAIR A-Series Lighting System. · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

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 ↗
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 ↗

Device details

UDI-DI	`00724995199913`
Brand	HarmonyAIR
Model	A-Series Lighting System
Catalog no.	LAH24NCNDA
Company	Steris Corporation
Product code	FSY · Light, surgical, ceiling mounted
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 19, 2021

Device type (GMDN): Operating room light system

An assembly of devices designed to provide specialized sources of light for illumination of a site of medical intervention. It typically consists of a combination of the light heads that may be of equal or unequal size, or a combination of operating and examination/treatment lights (commonly known as satellite lights) mounted on independent rotating counterbalanced arms allowing the positioning of the lights to any position. This device is usually mounted to the ceiling of an operating room (OR) and it may include cameras, visual display units (VDU) or other devices.

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All Light, surgical, ceiling mounted devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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