BEUDAMED
    FDA Enforcement Class II Terminated

    DigitalDiagnost Upgrades (Stitching Patient Support) 712083

    Recall: Z-2864-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2864-2018
    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 Upgrades (Stitching Patient Support) 712083

    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: 437736/SN09000282 491574/SN12000099 488712 415314/SN0902058 445533/SN10000006 414930/SN08000055 SN13000238 SN13000214 504759/SN12000356 487719/SN11000538 504766/SN12000207 SN14000264 SN14000264 469223/SN10000643 493888/SN12000004 316236 306773 306776 334582 325938 SN08000301 396570/SN0802320 SN08000216

    Distribution

    US Nationwide; International to 66 countries