BEUDAMED
    FDA Enforcement Class II Terminated

    DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028

    Recall: Z-2850-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2850-2018
    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 Flex / Value (Stitching Patient Support) 712028

    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: SN17000283 SN15000078 SN15000115 SN17000326 SN15000114 SN17000171 SN17000058 SN17000190 SN15000016 SN15000316 SN17000027 SN14000047 SN17000024 SN15000015 SN17000342 SN14000108

    Distribution

    US Nationwide; International to 66 countries