BEUDAMED
    FDA Recall Completed

    Elekta Unity

    Recall: Z-0706-2019 · Initiated January 4, 2019

    Recall

    Recall Number
    Z-0706-2019
    Event Number
    81886
    Firm
    Elekta Limited Linac House Fleming Way Crawley United Kingdom
    FEI Number
    3002806900
    Product Code
    IYE
    Status
    Completed
    Root Cause
    Under Investigation by firm
    Initiated
    January 4, 2019

    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.

    Action

    The firm notified their consignees about the issue on 01/04/2019 and will install additional fixation.

    Distribution

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

    Quantity

    2 units