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Health Canada Health products

HarmonyAIR A-Series Surgical Lighting System AND ALYON Surgical Lighting System

Issued April 14, 2026
Issue
Product HarmonyAIR A-Series Surgical Lighting System AND ALYON Surgical Lighting System Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information. Audience Healthcare
Hazard description
Steris identified through customer complaints that on Harmonyair A-Series Lighting System and Alyon Surgical Lighting System the plus/minus (+/-) buttons that control light intensity on the light heads may detach. If detachment occurs during a patient procedure, the buttons could enter the sterile field and disrupt the procedure resulting in a procedure delay. Users can continue to use their lighting system(s) prior to completion of the correction. Users are reminded to ensure no excess fluids remain on light head during or after cleaning, per the operator manual. Should detachment of the plus/minus (+/-) buttons occur prior to the correction being completed, users should immediately contact their local Steris representative.
Reference
ID
RA-82097