BEUDAMED
    FDA Recall Terminated

    SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743

    Recall: Z-2334-2015 · Initiated July 14, 2015

    Recall

    Recall Number
    Z-2334-2015
    Event Number
    71712
    Firm
    Siemens Medical Solutions USA Inc.
    FEI Number
    1034973
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    July 14, 2015
    Posted
    August 5, 2015
    Terminated
    March 3, 2016
    Address
    810 Innovation Dr, Knoxville, TN, 37932-2562

    Description

    SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743

    Reason

    Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.

    Action

    The firm initiated their recall on 07/14/2015 by telephone to the sole US consignee. The update is scheduled for 07/15/2015.

    Distribution

    Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.

    Quantity

    1 unit