BEUDAMED
    FDA Enforcement Class II Terminated

    UroDiagnost Eleva, system code 708033

    Recall: Z-1492-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1492-2020
    Event ID
    84756
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2020
    Initiation Date
    December 30, 2019
    Classification Date
    March 13, 2020
    Termination Date
    November 17, 2022
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    UroDiagnost Eleva, system code 708033

    Reason

    A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.

    Code Info

    Serial numbers 64 48 2 60

    Distribution

    Nationwide domestic distribution. Foreign distribution worldwide.

    Quantity

    4