BEUDAMED
    FDA Enforcement Class II Terminated

    Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.

    Recall: Z-1519-2016 · Reported April 27, 2016

    Enforcement

    Recall Number
    Z-1519-2016
    Event ID
    73593
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    April 27, 2016
    Initiation Date
    March 2, 2016
    Classification Date
    April 19, 2016
    Termination Date
    December 13, 2016
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355-1418, United States

    Description

    Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.

    Reason

    Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.

    Code Info

    Model Number: 8098027 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.

    Distribution

    Nationwide Distribution-including DC, and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.

    Quantity

    1096