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
RecallTracker