BEUDAMED
    FDA Enforcement Class II Terminated

    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

    Recall: Z-2843-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2843-2018
    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: SN15000196 SN15000180 SN15000282 SN15000281 SN15000192 SN15000189

    Distribution

    US Nationwide; International to 66 countries