BEUDAMED
    FDA Enforcement Class II Terminated

    Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)

    Recall: Z-1487-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1487-2020
    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

    Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)

    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 3217017 200 58 72 CV.170 180 524615 47 211 364 30 3862570/0011 529 S.N. 519 S01H060871 505/0050114 S01H057274 01H077213 530 532 S01HA52566 348 476 320 481 467 284 352 359 459 73*004 733 536 CV.474 454 49 281 51 186 122 250 37 22 CV.312 296 373 CV.596 176 30 580 279

    Distribution

    Nationwide domestic distribution. Foreign distribution worldwide.

    Quantity

    70