BEUDAMED
    FDA Enforcement Class II Completed

    Elekta Unity

    Recall: Z-0706-2019 · Reported January 16, 2019

    Enforcement

    Recall Number
    Z-0706-2019
    Event ID
    81886
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Elekta Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 16, 2019
    Initiation Date
    January 4, 2019
    Classification Date
    January 9, 2019
    Address
    Linac House, Fleming Way, Crawley, N/A, United Kingdom

    Description

    Elekta Unity

    Reason

    In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.

    Code Info

    Serial Numbers: 1536549, 1536549

    Distribution

    TX and WI, Germany, Denmark, Netherlands, United Kingdom

    Quantity

    2 units