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Dual flat panel monitor (dfpm) accessory to the harmonyair® a-series and e-series surgical lighting systems
Official notice
24 Jun 2025
An official Health Canada notice concerns Dual flat panel monitor (dfpm) accessory to the harmonyair® a-series and e-series surgical lighting systems. Steris identified that the DFPM yoke assembly may detach from the spring arm. Should this occur, the yoke assembly is expected to hang by its wiring rather than fully detach, potentially requiring patient transfer and causing a procedure delay. In addition, the yoke assembly could come in contact with the user or patient during detachment. This could result in an injury. Users are requested to review revised preventive maintenance manual and interval based check list language for the HarmonyAIR® a series surgical lighting system and immediately complete maintenance activities as instructed. Recall start date: June 13, 2025 Published 2025-06-24.
What to do now
Contact the manufacturer if you require additional information.
Recall number
77643
Official notice
2025-06-24
The hazard
The hazard
Steris identified that the DFPM yoke assembly may detach from the spring arm. Should this occur, the yoke assembly is expected to hang by its wiring rather than fully detach, potentially requiring patient transfer and causing a procedure delay. In addition, the yoke assembly could come in contact with the user or patient during detachment. This could result in an injury. Users are requested to review revised preventive maintenance manual and interval based check list language for the HarmonyAIR® a series surgical lighting system and immediately complete maintenance activities as instructed. Recall start date: June 13, 2025
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Brand: Steris, Dual Flat Panel Monitor Accessory To The Harmonyair® A-series And E-series Surgical Lighting.
Source & status
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