BEUDAMED
    FDA Enforcement Class II Ongoing

    Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems

    Recall: Z-2178-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2178-2025
    Event ID
    97068
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2025
    Initiation Date
    June 23, 2025
    Classification Date
    July 25, 2025
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834, United States

    Description

    Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems

    Reason

    The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.

    Code Info

    UDI: 00724995171155: Serial numbers: 0416920048, 0417820084, 0417820088, 0417820096, 0417820110, 0417820092, 0417820100, 0418420047, 0419620004, 0419520013, 0428620109, 0428620112, 0430020191, 0431720044, 0435120043, 0435120047, 0435120051, 0401321042, 0413221047, 0413221199, 0413721008, 0413721012, 0417221023, 0417221027, 0417221031, 0420021018, 0420021022, 0420021026, 0420721021, 0429720003, 0420921073, 0426321186, 0426321190, 0427121121, 0427121125, 0427321012, 0427321002, 0427321005, 0413921017, 0434121095, 0434121098, 0434121101, 0434121104, 0434121107, 0434121110, 0434121113, 0400722081, 0406022021, 0406022025, 0406022034, 0406022038, 0406022017, 0406022014, 0406022011, 0417122078, 0417122081, 0417122084, 0417122087, 0417122090.

    Distribution

    Worldwide - US Nationwide and Puerto Rico and the country of Canada.

    Quantity

    59 units