BEUDAMED
    FDA Enforcement Class I Terminated

    DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

    Recall: Z-2971-2018 · Reported September 26, 2018

    Enforcement

    Recall Number
    Z-2971-2018
    Event ID
    80628
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pro-Med Instruments Gmbh
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 26, 2018
    Initiation Date
    July 5, 2018
    Classification Date
    September 17, 2018
    Termination Date
    November 19, 2020
    Address
    Botzinger Str. 38, N/A, Freiburg Im Breisgau, N/A, N/A, Germany

    Description

    DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

    Reason

    The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.

    Code Info

    Serial Numbers: 1704002 1704004 1704005 1704007 1704011 1704041 1704010 1704012 1704019 1704037 1704014 1704016 1704017 1704021 1704024 1704025 1704036 1704038 1704018 1704008 1704034 1704026 1704027 1704028 1704029 1704030 1704032 1704035 1704006 1704037 1704039 1709014

    Distribution

    Worldwide distribution to US states of CA, TX, TN, MS, GA, WV, and OH, Qatar, India, UK, Singapore, Australia, Germany, South Africa, Italy, and Japan

    Quantity

    31 units