Official recall record

Dual Flat Panel Monitor (DFPM) Accessory To The HarmonyAIR® A-Series And E-Series Surgical Lighting Systems

Health Canada — Medical Devices · 2025-06-24 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2025-06-24
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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