FDA DeviceClass IINotable

FDA Recall: HarmonyAIR A-Series Surgical Lighting System

Date: 2026-06-24
Brand: Steris Corporation
Category: Medical Device
FDA Class: Class II

Description

The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

Hazard

The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

Remedy

2101 units

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