BEUDAMED
    FDA Recall Terminated

    DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries

    Recall: Z-2970-2018 · Initiated July 5, 2018

    Recall

    Recall Number
    Z-2970-2018
    Event Number
    80628
    Firm
    Pro-Med Instruments Gmbh Botzinger Str. 38 Freiburg Im Breisgau Germany
    FEI Number
    3003923584
    Product Code
    HBL
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    July 5, 2018
    Posted
    September 17, 2018
    Terminated
    November 19, 2020

    Description

    DORO LUCENT Base Unit, REF 1101.021 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.

    Action

    The firm initiated the recall by email on 07/05/2018. This stage is only relevant for hospitals / users who are in possession with concerned products of two different revisions (mix-up): a) Discontinue the use of the combination and quarantine the concerned products b) Contact pro med instruments for further instructions relating to temporary replacement possibilities

    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

    30 units