BEUDAMED
    FDA Enforcement Class II Terminated

    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

    Recall: Z-2855-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2855-2018
    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 4.1 High Performance (Stitching Patient Support) 712031

    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: SN15000291 SN16000158 SN15000374 SN15000298 SN16000191 SN15000327 SN17000317 SN16000321 SN16000063 SN15000364 SN15000444 SN16000143 SN15000443 SN16000037 SN15000371 SN15000303 SN16000137 SN16000329 SN16000095 SN16000308 SN16000328 SN16000043 SN16000151 SN15000442 SN16000147 SN16000146 SN16000050 SN16000271 SN16000253 SN16000073 SN16000296 SN16000297 SN16000311 SN16000263 SN16000371 SN16000214 SN16000142 SN16000025 SN16000165 SN16000105 SN15000264 SN16000264 SN16000302 SN16000113 SN16000112 SN16000123 SN15000373 SN15000165 SN16000347 SN16000375 SN15000355 SN16000225

    Distribution

    US Nationwide; International to 66 countries