BEUDAMED
    FDA Enforcement Class II Terminated

    OmniDiagnost Eleva System codes 708028 708027

    Recall: Z-1490-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1490-2020
    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

    OmniDiagnost Eleva System codes 708028 708027

    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 codes 152 49 514 179 611 C@23273 46 560 555 464 14 90 198 15 326 143*003 451 267 FR90-111 417 59 390 164 135 23 143 80 219 24 78 73 15 79 109 624 71 44 576 70 460 62 98 63 620 147 100 68 122 422 12 54 490 97 138 20 130 67 ON100031011SN273 241 435 125 89 47 17 33 134 574

    Distribution

    Nationwide domestic distribution. Foreign distribution worldwide.

    Quantity

    69