BEUDAMED
    FDA Enforcement Class II Terminated

    DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028

    Recall: Z-2854-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2854-2018
    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 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: SN16000197 SN15000288 SN16000234 SN16000008 SN15000304 SN15000283 SN15000174 SN15000225 SN16000124 SN16000023 550162 SN15000350 SN16000092 SN15000379 SN16000283 SN16000104 SN15000173

    Distribution

    US Nationwide; International to 66 countries