BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1518-2016 · Initiated March 2, 2016

    Recall

    Recall Number
    Z-1518-2016
    Event Number
    73593
    Firm
    Siemens Medical Solutions USA, Inc
    FEI Number
    2240869
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 2, 2016
    Posted
    April 19, 2016
    Terminated
    December 13, 2016
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418

    Description

    Siemens SOMATOM Definition: 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, re-scans 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.

    Action

    Siemens initiated a Customer Advisory Notice on 03/07/2016 to inform customers about actions for bug-fixing the following systems: SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge, which could possibly cause scan aborts, res cans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium. Siemens mailed certified as well as via email distribution a Customer Advisory Notice to their customers to inform them about corrective actions for bug-fixing the following systems running with software version VA44A_SP3a, VA44A_SP3b, VA44A_SP3c, correction of potential safety issues. The issues described will be corrected with software VA44_SP4, handled as update CT051/15/P. Following the installation of this update, the mentioned malfunctions will be corrected.

    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