BEUDAMED
    FDA Enforcement Class II Terminated

    EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050

    Recall: Z-2868-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2868-2018
    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

    EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050

    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: SN17000027 SN16000011 SN16000014 SN16000036 SN16000015 SN15000050 476034/SN12000027 476338/SN12000026 SN17000022 SN15000029 SN16000017 SN16000009 SN13000078 SN16000048 SN16000004 SN13000029 SN14000068 511923/SN12000044 514827/SN12000098 514827/SN12000098 SN14000044 ***Updated 5/6/21*** SN15000055

    Distribution

    US Nationwide; International to 66 countries