BEUDAMED
    FDA Enforcement Class II Ongoing

    UROSKOP Omnia Max. Model Number: 10762473

    Recall: Z-1982-2025 · Reported June 25, 2025

    Enforcement

    Recall Number
    Z-1982-2025
    Event ID
    97050
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 25, 2025
    Initiation Date
    June 4, 2025
    Classification Date
    June 17, 2025
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    UROSKOP Omnia Max. Model Number: 10762473

    Reason

    A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

    Code Info

    Model Number: 10762473. UDI Numbers: (01)04056869008981(21)4014, (01)04056869008981(21)4056, (01)04056869008981(21)4049, (01)04056869008981(21)4015, (01)04056869008981(21)4063, (01)04056869008981(21)4022, (01)04056869008981(21)4036, (01)04056869008981(21)4043, (01)04056869008981(21)4024, (01)04056869008981(21)4059, (01)04056869008981(21)4020, (01)04056869008981(21)4032, (01)04056869008981(21)4053, (01)04056869008981(21)4061, (01)04056869008981(21)4060, (01)04056869008981(21)4051, (01)04056869008981(21)4025, (01)04056869008981(21)4037, (01)04056869008981(21)4054, (01)04056869008981(21)4042, (01)04056869008981(21)4033, (01)04056869008981(21)4055, (01)04056869008981(21)4052, (01)04056869008981(21)4047, (01)04056869008981(21)4062. Serial Numbers: 4014, 4056, 4049, 4015, 4063, 4022, 4036, 4043, 4024, 4059, 4020, 4032, 4053, 4061, 4060, 4051, 4025, 4037, 4054, 4042, 4033, 4055, 4052, 4047, 4062.

    Distribution

    Nationwide distribution.

    Quantity

    25 units