BEUDAMED
    FDA Enforcement Class II Terminated

    DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062

    Recall: Z-2866-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2866-2018
    Event ID
    80577
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems Gmbh, DMC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    June 27, 2018
    Classification Date
    August 17, 2018
    Termination Date
    April 30, 2024
    Address
    Development And Manufacturing Ctr., Rontgenstr. 24, Hamburg, N/A, Germany

    Description

    DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062

    Reason

    The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

    Code Info

    Serial Numbers: 386786/SN0702512 375366 416255/SN0902004 358322 388667/SN0802105 375367 397229/SN0802250 396838/SN0802365 386108/SN0802044 405687/SN0802469 354125 362438 406156/SN0802537 413697/SN0802634 402853/SN0902012 405889/SN0802629 383385/SN0802011 378827/SN0802021 384013/SN0702495 358017 358496 377925/SN0802060 356953 355621 357888 356956 368431 356963 406016/SN0802476 346522 375370 70700 351321 392504/SN0802182

    Distribution

    US Nationwide; International to 66 countries