BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2334-2015 · Reported August 12, 2015

    Enforcement

    Recall Number
    Z-2334-2015
    Event ID
    71712
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 12, 2015
    Initiation Date
    July 14, 2015
    Classification Date
    August 5, 2015
    Termination Date
    March 3, 2016
    Address
    810 Innovation Dr, N/A, Knoxville, TN, 37932-2562, United States

    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.

    Code Info

    SERIAL NUMBER 11004

    Distribution

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

    Quantity

    1 unit